Recall – Drug Regulatory Authority of Pakistan

36. Recall Alert – Medical Devices Declared Substandard by CDL Karachi

Salateen Philip Recall Alerts July 14, 2026July 14, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI

DRAP Alert No	N^oI/S/07-26-36
Action Date	14 July, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Medical Devices have been declared “Substandard”.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturer / Importer details	Remarks
1	BD 10ML Syringe (MDMR-0000035)	5349764	Manufacturer: Becton Dickinson Medical (S) Pte. Ltd. 30 Tuas Avenue 2, Singapore. Importer: M/s Asto Life Sciences (Pvt.) Ltd. Plaza #1, Block Orchard-1, Gate #2, Paragon City, Barki Road, Lahore. (ELI-00103)	Substandard on the basis of Absorbance test.
2.	Accuject Auto-Disable Syringe 5ml (MDMR-000507)	S502E26	Manufacturer: M/s Faiz Surgical and Medical Industries (Pvt.) Ltd. Plot No. 540-B, Sundar Industrial Estate, Lahore. (ELM-0093)	Substandard on the basis of Sterility test.

Risk Statement:	The affected batches have been declared substandard due to failure of critical quality tests. The BD 10 mL Syringe (Batch No. 5349764) failed the Absorbance test, indicating excessive extractable substances that may compromise product safety and quality for parenteral use. The Accuject Auto-Disable Syringe 5 mL (Batch No. S502E26) failed the Sterility test, indicating possible microbial contamination that may increase the risk of infection, including serious systemic infections, upon use.
Action Initiated	-The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

35. Recall Alert – DTL Punjab Declared Substandard Drug Products.

Salateen Philip Recall Alerts June 18, 2026June 18, 2026Recall

Recall Alert


	DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES

DRAP Alert No	N^oI/S/06-26-35
Action Date	18 June, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard/Adulterated’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Remarks
1.	Neocobal 0.5 mg Injection Each ml contains: Mecobalamin ……..0.5mg (Reg. # 071447)	S-3052	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
2.	GAMMARAAS Injection Immune Globulin Injection (Human) 5%, 2.5g, 50ml/vial (Reg. # 031350)	202311G042	*Imported & Distributed by* Popular International (Pvt.) Ltd. 141, Justice Inamullah Road, Block 7 & 8 KMCHS, Karachi.	The sample is declared as “sub-standard” with regards to Description & Sterility test.
3.	Injection. KAMEDEX 1mL Each ml contains: Dexamethasone Sodium Phosphate eq. to Dexamethasone phosphate 4 mg (Reg. # 074983)	DX-2642	M/s Amaan Pharma. 30-Km Sheikhupura Road Lahore (DML # 000808)	The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).
4.	BRZOLE 500mg/100ml Infusion Each vial contains: Metronidazole….500mg/100ml (Reg. # 099612)	25055	M/s Berlex Lab. International, 10-Km Nangshah Chowk Karachi Road Multan (DML # 000678)	The sample is declared as “sub-standard” with regards to Bacterial Endotoxin test.
5.	Metrorise Infusion Metronidazole….500mg/100ml (Reg. # 040412-D)	LV-2514	M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)	The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test & Visible particles.
6.	Murcobal Injection 500 mcg Each ml Contains Mecobalamin…500mcg (Reg. # 045904)	109	M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543)	The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
7.	Premvil Infusion 1gm/100 ml Each l00ml contains: Paracetamol………….1gm (Reg. # 125218)	PNO-2510	Ahad International Pharmaceutical LTD 13-Km, Multan Road, Dera Ismail Khan	The sample is declared as “sub-standard” with regards to Visible Particulates
8.	Aqua-P Injection Sterile water for injection 5ml	P-673	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	Sub-standard’ on the basis of Bacterial Endotoxin Test.
9.	ZYOCAIN Gel Lignocaine Hydrochloride B.P 2% w/v (Reg # 012523)	008	M/s PharmaWise Labs (Pvt) Ltd. 25-M Industrial Area Kot Lakhpat Lahore. (DML # 000182)	Sub-standard’ on the basis of Sterility test
10.	Injection Cara-Lac 30mg/1ml Each 1ml contains: – Ketorolac Tromethamine equivalent to Ketorolac………30mg (Reg. # 054997)	25G022	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	The sample is declared as “sub-standard” on the basis of Test for Impurities i.e. Organic Impurities.
11.	Sterile Water for Injection 5ml	20334	M/s NovaMed Pharmaceuticals (Pvt) Ltd. 28-Km Ferozepur Road Lahore (DML # 000590)	Sub-standard’ on the basis of Bacterial Endotoxin Test.

Risk Statement:	The affected products have been found to possess critical quality defects, including failure of sterility, bacterial endotoxin, assay, impurity, and visible particulate tests, while certain products were also declared adulterated due to misidentified active ingredients or misleading composition. Use of these products may result in treatment failure, serious infections, pyrogenic reactions, adverse health effects, or other patient safety risks. Healthcare professionals, distributors, and retailers are therefore advised to immediately cease distribution and use of the affected batches and ensure their prompt recall from the market.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

34- Recall Alert- DTL Sindh declared Substandard Auto Disable Syringes

Salateen Philip Recall Alerts June 8, 2026June 8, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES

DRAP Alert No	N^oI/S/06-26-34
Action Date	08 June, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory Sindh, Karachi has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Therapeutic Goods (s) Affected: –

S#	Product Name	Manufacturer / Importer & Address	Batch No.	Remarks
1	Clinic Auto Disable Syringe 3ml (MDMR-000115)	M/s Surgi Plast Pvt. Ltd., Plot # 78, Road No. L-4, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan (ELM # 0030)	3-01B-26	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
2.	Medi Aqua Auto Disable Syringe 3ml (MDMR-000145)	M/s Frontier Pharmaceutical (Pvt.) Ltd., (ELM # 0042) W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan	AD1B25	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
3.	Ultra Fine SMD Painless 3ml Syringe (MDMR-000229)	M/s Sehat Medical Devices (Pvt.) Ltd., Plot # 473, Sundar Industrial Estate, Lahore, Pakistan (ELM # 0065)	3088CL & 3090CL & 3013DC	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Risk Statement:	Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

30. Recall Alert – CDL Declared Sub-standard Medical Devices

Salateen Philip Recall Alerts June 1, 2026June 1, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI

DRAP Alert No	N^oI/S/06-26-30
Action Date	01 June, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Auto Disable Syringes have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Therapeutic Goods (s) Affected: –

S#	Product Name	Manufacturer / Importer & Address	Batch No.	Remarks
1	Zindagi Auto Disable Syringes 3ml/cc (MDMR-000117)	Manufacturer: M/s Al-Badar Manufacturing (Pvt.) Ltd. Plot No. 193/3, Road No. 7, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, (ELM-0029)	3-01B-26	Substandard
2	Zindagi Auto Disable Syringes 3ml/cc (MDMR-000117)		3-01A-26	Substandard
3.	Biosoft Auto Lock Safety Syringe 3cc/ml (MDIR-0002506)	Manufacturer: M/s Jiangxi Fenglin Medical Appliances Co. Ltd, Jiangxi China Importer: M/s Hashir Surgical Services Office No 16, Street 1, F-2, Phase 6, Hayatabad, Peshawar	20250810	Substandard
4.	I.CO Safety Syringe 5ml (MDIR-0002291)	Importer: M/s Capra-Med (Pvt) Ltd First Floor 81, Broadway Commercial, Paragon City Barki Road, Lahore Manufacturer: M/s Med ELDawlaico International Company for Medical Necessities	2510	Substandard
5.	Injekt Auto Disable Syringe 3ml (MDMR-000147)	Manufacturer: Lahore Medical Instruments (Pvt.) Ltd. Kasur	3-018	Substandard
6.	Yashfaeen Sterile Self Destruction Safety Syringe 3ml [Auto Disable Syringe] (MDIR-0006365)	Importer: M/s Tech Zone Ground Floor, Weal House 8, Faiz Road, Old Muslim Town, Lahore. Manufacturer: M/s Shandong Caremed Medical Products Co., Ltd., (Yantai) Industrial park, Dingtao County, Heze 274100 Shandong PR China	20250930	Substandard
7.	Yashfaeen Sterile Self Destruction Safety Syringe 5ml [Auto Disable Syringe] (MDIR-0006365)	Importer: M/s Tech Zone Ground Floor, Weal House 8, Faiz Road, Old Muslim Town, Lahore. Manufacturer: M/s Shandong Caremed Medical Products Co., Ltd., (Yantai) Industrial park, Dingtao County, Heze 274100 Shandong PR China	20250930	Substandard

Risk Statement:	Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures.
Action Initiated	-The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

29. Recall Alert – DTL Sindh declared Substandard Auto Disable Syringes

Salateen Philip Recall Alerts May 22, 2026May 22, 2026Recall

Recall Alert


	DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES

DRAP Alert No	N^oI/S/05-26-29
Action Date	22^nd May, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory Sindh, Karachi has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Therapeutic Goods (s) Affected: –

S#	Product Name	Manufacturer / Importer & Address	Batch No.	Remarks
1	Medi Aqua Auto Disable Syringe 5ml (MDMR-000145)	M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan	AD1C25	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
2	Zindagi Auto Disable Syringe 3ml (MDMR-000117)	M/s Al-Badar Manufacturing (Pvt.) Ltd., Plot No.193/3, Road No.7, Industrial Estate Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan	3-OL-25	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
3	Shifa Auto Destruct Syringe 3ml (MDIR-0002262)	Importer: M/s SY’AH Impex, 1-6/15 Sector-5, Korangi Industrial Area, Karachi. Manufacturer: M/s Changzhou Tongda Medical Appliance Co., Ltd., Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, Jiangsu, China.	20251210	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
4	Unilock Auto Disable Syringe 3ml (MDMR-000138)	M/s Unisa (Pvt.) Ltd., Main G.T. Road, Adamzai, Akora Khattak, District Nowshera, Khyber Pakhtunkhwa, Pakistan	2506303	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
5	Shifa Auto Destruct Syringe 5ml (MDIR-0002262)	Importer: M/s SY’AH Impex, 1-6/15 Sector-5, Korangi Industrial Area, Karachi. Manufacturer: M/s Changzhou Tongda Medical Appliance Co., Ltd., Sanhekou Street, Zhenglu Town, Tianning District, Changzhou, Jiangsu, China.	20251020	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
6	Bio Safe Auto Disable Syringe	M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan	X25L01	Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Risk Statement:	Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

28. Recall Alert – CDL Karachi declared substandard Auto Disable Syringes.

Salateen Philip Recall Alerts May 22, 2026May 22, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI

DRAP Alert No	N^oI/S/05-26-28
Action Date	22^nd May, 2026
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Auto Disable Syringes have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

Therapeutic Goods (s) Affected: –

S#	Product Name	Manufacturer / Importer & Address	Batch No.	Remarks
1	Ultra Fine SMD Painless Syringe 3ml (MDMR-000229)	Manufacturer: M/s Sehat Medical Devices (Pvt.) Ltd., Lahore, Pakistan	3008DA	Substandard
2	Ultra Fine SMD Painless Syringe 3ml (MDMR-000229)	Manufacturer: M/s Sehat Medical Devices (Pvt.) Ltd., Lahore, Pakistan	3016DC	Substandard
3	Venus Auto-Disable Syringe 5ml (MDMR-000453)	Manufacturer: M/s Bioron Medics (Pvt.) Ltd., Lahore, Pakistan	082602002	Substandard
4	Venus Auto-Disable Syringe 3ml (MDMR-000453)	Manufacturer: M/s Bioron Medics (Pvt.) Ltd., Lahore, Pakistan	072602002	Substandard
5	Medi Aqua Auto Disable Syringe 3ml (MDMR-000145)	Manufacturer: M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan	AD1B25	Substandard
6	Medi Aqua Auto Disable Syringe 5ml (MDMR-000145)	Manufacturer: M/s Frontier Pharmaceutical (Pvt.) Ltd., W-10, Industrial Estate, Jamrud Road, Peshawar, Pakistan	AD1C25	Substandard
7	Clinic Auto Disable Syringe 3ml/cc (MDMR-000115)	Manufacturer: M/s Surgi Plast Industries, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan	3-01C-26	Substandard
8	Clinic Auto Disable Syringe 3ml/cc (MDMR-000115)	Manufacturer: M/s Surgi Plast Industries, Industrial Estate, Gadoon Amazai, District Swabi, Khyber Pakhtunkhwa, Pakistan	3-01B-26	Substandard
9	Bio Safe Auto Disable Syringe	Manufacturer: M/s Injection Systems (Pvt.) Ltd., Plot No. 271, Main Road, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan	Y26CO1	Substandard
10	Medline Sterile Auto-Disable Syringe with Needle (MDIR-0001535)	Importer: M/s Platinum Corporation, F-10/7/6 Near Arfeen Masjid, Barrage Colony, Sukkur, Pakistan. Manufacturer: M/s Yangzhou Medline Industry Co., Ltd.China.	20240910	Substandard
11	L.D Tru-Lock Auto-Disable Syringe 3ml/5ml (MDMR-000174)	Manufacturer: M/s Lasani Healthcare, Plot No. 29-A/R-1, Industrial Estate, Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan	2604- 54TL3	Substandard

Risk Statement:	Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures.
Action Initiated	-The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

26. Recall Alert (Human) – DTLs Punjab declared Substandard products

Salateen Philip Recall Alerts May 4, 2026May 4, 2026Recall

Recall Alert


	DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES

DRAP Alert No	N^oI/S/05-26-26
Action Date	04 May, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Remarks
1.	ZYOCAIN Gel Lignocaine Hydrochloride B.P 2% w/v (Reg # 012523)	G026	M/s PharmaWise Laba. (Pvt.) Ltd. Formerty Fakma Pharma 25-41 QA Induatrial Estate, Lahore-Pakistan (DML # 000182)	The Sample is declared as “sub-standard” on the basis of Sterility Test.
2.	Neocobal Injection 0.5/mg Each ml contains: Mecobalamin……..0.5mg (Reg # 071447)	S-3050	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
3.	Injection Neutroline 10 ml Water for injection 10ml (Reg # 096698)	L387	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The Sample is declared as “sub-standard” on the basis of Endotoxin Test.
4.	CARA-DOBA Injection Each 5mL ampoule contains Dobutamine HCL USP Eq to Dobutamine …. 250mg (Reg # 054987)	25E004	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	The sample is sub-standard, on the basis “Physical description” and “Visible particulate matter” tests.
5.	PAINSTOP Injection Each 3ml contains Diclofenac Sodium B.P………75mg (Reg # 023730)	PS-090, PS-091	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The above sample is sub-standard on the basis “Physical Description-Visible Particulate matter”.
6.	SENSOCAIN Injection Each ml contains: Bupivacaine Hydrochloride …. 5 mg (Reg # 047396)	172K25	M/s Brookes Pharma Private Limited 58-59 Sector 15 Korangi Industrial Area Karachi. (DML # 000275)	The sample is sub-standard on the basis of Sterility test.
7.	Tablet Kadin 2 mg Each Tablet Contains Tizanidine (as Hydrochloride) … 2mg (Reg # 033347)	570	M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494)	The sample is declared as “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Paracetamol identified).
8.	Infusion. GEE-SOL NS 1000ML Sodium Chloride 0.9% w/v (Reg # 080418)	26A025	M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817)	The sample is sub-standard, on the basis of Bacterial Endotoxins Test.
9.	Infusion. GEE-SOL RL 500ml (Compound Sodium Lactate) (Reg # 080910)	25MM264	M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817)	The sample is sub-standard, on the basis of Bacterial Endotoxins Test.

Risk Statement:	The identified products present moderate to high public health risk, particularly because several are parenteral (injectable/infusion) preparations, which bypass natural body defenses. Failures in sterility and endotoxin tests (e.g., ZYOCAIN Gel, SENSOCAIN, Neutroline, GEE-SOL infusions) can lead to sepsis, pyrogenic reactions, or life-threatening infections, especially in hospitalized, immunocompromised, pediatric, and ICU patients, who are the most vulnerable. Products with visible particulate matter (CARA-DOBA, PAINSTOP) pose risks of embolism, inflammation, and organ damage. Adulterated medicines (Neocobal, Kadin) indicate serious quality breaches, potentially causing therapeutic failure, unexpected pharmacological effects, or toxicity, undermining clinician trust and treatment outcomes. The most likely affected population includes inpatients in public/private hospitals, emergency care recipients, and patients receiving IV therapy, where such products are commonly used. Overall, these defects reflect critical lapses in manufacturing quality systems, with the highest risk concentrated in injectables and infusions used in acute care settings.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

25. Recall Alert (Human) – CDL Declared Substandard products.

Salateen Philip Recall Alerts May 4, 2026May 4, 2026Recall

Recall Alert


	DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI

DRAP Alert No	N^oI/S/05-26-24
Action Date	04 May, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Remarks
1.	WAFIN Injection Each ampule contains: – Water for Injection …. 5ml (Reg # 066643)	250101	M/s Crest Pharmaceuticals. 43 Idustrial Triangle Kahuta Road. Islamabad (DML # 000694)	The sample has been declared “substandard” on the basis of sterility test.
2.	Maverick 500 mg Injection Each vial contains: – Ceftriaxone Sodium eq. to Ceftriaxone …. 500 mg (Reg # 065444)	250901		The sample has been declared “substandard” on the basis of sterility test.

Risk Statement:	Both WAFIN Injection (Water for Injection 5 ml) and Maverick 500 mg Injection (Ceftriaxone Sodium) have been declared substandard due to sterility failure, posing a serious risk of microbial contamination that may lead to severe infections, including septicemia. The most likely affected population includes hospitalized patients, especially those in ICUs, immunocompromised individuals, pediatric and elderly patients, and those receiving intravenous antibiotic therapy.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

24. Recall Alert – Veterinary Drug Products declared Substandard by DTL Punjab

Salateen Philip Recall Alerts April 14, 2026April 14, 2026Recall

Recall Alert

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/04-26-24
Action Date	14 April, 2026.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Provincial Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as *‘Substandard’*.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch	Manufacturer details	Remarks
1	Injection MAC ROLD 1% 10ml Ivermectin: 10 mg/ml (Reg # 106804)	YI-152	M/s Haarolds Pharmaceuticals (Pvt.) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921)	The sample is declared as “misbranded” as per Section 3(s)(vi) of The Drugs Act 1976 and “SUB-STANDARD” on the basis of Assay Test and Test for Related Substances.

Risk Statement:	The use of this substandard and misbranded veterinary ivermectin injection may lead to ineffective parasite control, development of drug resistance, and potential toxicity in animals due to incorrect potency and presence of impurities. This can adversely affect animal health, productivity, and may pose indirect risks to public health through the food chain. Livestock animals (cattle, sheep, goats) treated for parasitic infections, particularly in commercial farming settings, and farmers relying on effective deworming for animal health and productivity.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

23. Recall Alert – Class II – Drug Products – Provincial reports

Salateen Philip Recall Alerts April 14, 2026April 14, 2026Recall

Recall Alert


	DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oI/S/03-26-23
Action Date	14 April, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories informed that the samples of below mentioned drug products have been declared as ‘Substandard ’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Remarks
1.	Tablet Nitras Each sustained release tablet contains: Glycerin Trinitrate …. 2.6 mg (Reg # 056007)	24L069	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	The Sample is declared as “sub-standard” on the basis of Assay & Dissolution Test.
2.	Tablet Kadin 2 mg Each Tablet Contains: Tizanidine (as Hydrochloride) …… 2mg (Reg # 033347)	569	M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494)	The sample is declared as “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Paracetamol identified).
3.	Tablet Loratamin Each Film Coated Tablet Contains: Loratadine USP 10mg (Reg # 062647)	24	M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543)	The above sample is adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Paracetamol.
4.	ACEFYL COUGH SYRUP Each 5mL contains: Acefylline Piperazine….45mg, Diphenhydramine HCl…8mg (Reg # 023394)	ACH479	M/s NABIQASIM INDUSTRIES (PVT.) LTD., 17/24, Korangi Industrial Area, Karachi. (DML # 000105).	The above sample is ADULTERATED as per The Drugs Act 1976, 3 {a (i)} (The one unit of sample contains a glass piece in it).
5.	Tablet ORTIZIN/10mg Each film coated tablet contains. Cetirizine dihydrochloride U.S.P 10 mg (Reg # 025405)	25F135	M/s Obsons Pharmaceuticals. 209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416)	The sample is declared as “SUB-STANDARD” on the basis of Assay Test and Test for Impurities (Organic Impurities).

Risk Statement:	The use of these substandard and adulterated oral products may result in reduced therapeutic efficacy, unexpected adverse drug reactions, and serious safety concerns due to incorrect active ingredients, contamination (including glass particles), and failure to meet quality standards. This may lead to inadequate disease control, allergic reactions, or physical injury to patients. Patients using these medicines for cardiac conditions, allergies, muscle spasm, and cough particularly children, elderly individuals, and those with chronic illnesses who rely on consistent and safe oral medication therapy.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

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