Recall – Drug Regulatory Authority of Pakistan

47. Rapid Alert: Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34)

Farooq Aslam Recall Alerts October 27, 2026October 27, 2026Recall

Rapid Alert


	Falsified INFLUENZA VACCINE VAXIGRIP TETRA (BATCH # Y4B34)

DRAP Alert No	N^o I/S/10-26-47
Action Date	27th October, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers
Problem Statement	M/s Hoechst Pakistan Limited, Plot No. 23, Sector 22, Korangi Industrial Area, Karachi has informed that a Falsified drug product i.e. Vaxigrip Tetra, Quadrivalent Influenza Vaccine (Batch No. Y4B34) has been found to be available in the market.

Sr. No.	Name of Product	Batch number	Name of Manufacturer	Remarks
1	Vaxigrip Tetra Vaccine (Suspension for Injection in Pre-filled Syringe)	Y4B34	Purported to be manufactured by: M/s Sanofi Winthrop Industrie, France	The suspected batch i.e. Y4B34 has never been imported or distributed in Pakistan.

Risk Statement	The use of above-mentioned Falsified Vaccine i.e. Vaxigrip Tetra (Batch # Y4B34) may pose serious safety and quality concerns for Public Health
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been asked to conduct surveillance activities throughout the supply chain to confiscate the falsified product.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use the above-mentioned product and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

46. Recall Alert: Substandard Cikina Umblical Cord Clamp

Farooq Aslam Recall Alerts October 27, 2026October 27, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED (CIKINA UMBLICAL CORD CLAMP SUBSTANDARD BY DRUG TESTING LABORATORY PUNJAB, Rawalpindi

DRAP Alert No	N^oI/S/10-26-46
Action Date	27 October, 2026
Target Audience	– National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory Punjab, Rawalpindi has informed Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical device have been declared “Substandard” on the basis of Sterility Testing.

Sr. No.	Product Name	Name of Manufacturer/Importer	Batch Number	Remarks
1	CIKINA UMBILICAL CORD CLAMP (UMBILICAL CORD CLAMP) MDIR: 0003486	M/s Ningbo Greatcare Trading Co. Ltd, China; Marketed by: Al-Hamd Enterprises, FL-11/1/1, Block 6, Gulshan e Iqbal Karachi Karachi (ELI # 00285)	25495	The sample is SUBSTANDARD on the basis of Sterility test.

Therapeutic Goods (s) Affected: –

Risk Statement:	The sterility failure of the umbilical cord clamp may result in exposure of neonatal patients to microbial contamination. Due to the vulnerable patient population, inability of the user to detect the defect, and potential for serious infection including sepsis, the residual risk is considered unacceptable and requires immediate corrective and regulatory action.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments have been asked 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 the above-mentioned 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.

42. Recall Alert: SUBSTANDARD & MISBRANDED CLINIC DISPOSABLE SYRINGES 20ML BY M/S SURGI PLAST, GADOON AMAZAI, KPK

Farooq Aslam Recall Alerts October 20, 2026October 20, 2026Recall

Recall Alert


	MEDICAL DEVICES (SYRINGES) DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES MANUFACTURED BY M/S SURGI PLAST, GADOON AMAZAI, KPK

DRAP Alert No	N^oI/S/10-26-42
Action Date	08 June, 2026
Target Audience	– – National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory, Lahore has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices (Syringes) have been declared “Substandard” on the basis of Sterility Testing and Misbranded on the basis of labelling as two needle gauges are mentioned on label.

Sr. No.	Product Name	Name of Manufacturer/Importer	Batch Number	Remarks
1	CLINIC Disposable Syringes 20mL	M/s SURGI PLAST Plot # 78, Road no. L-4, Industrial Estate Gadoon Amazai, KPK. (ELM-0030)	20-01G-25	The sample is SUBSTANDARD on the basis of Sterility test and MISBRANDED on the basis of labelling as two needle gauges are mentioned on label.

Therapeutic Goods (s) Affected: –

Risk Statement:	The syringes may pose a risk of infection or other harm because they failed sterility testing. The label also lists two different gauges, which may lead to selection or use of the wrong syringe size. The use of a non-sterile syringe could introduce microorganisms into the patient, potentially causing local or systemic infection. The conflicting gauge information may also result in incorrect device selection, affecting the intended procedure or medication delivery.
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.

41. Recall Alert: WFI (Batch # W-174), M/s City Pharmaceutical Laboratories (DML#00723)

Salateen Philip Recall Alerts October 19, 2026October 19, 2026Recall

Recall Alert


	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY CENTRAL DRUGS 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 Testing Laboratory, Karachi informed that the samples of diluent i.e. Water for Injection (Batch # W-174) in the combo-pack of the below mentioned drug products have been declared as ‘Substandard’ based on presence of visible particles.

Therapeutic Goods (s) Affected: –

Sr. No.	Product Name	Batch Numbers	Manufacturers
1.	Exoran-500mg Injection vial	P-240 P-239	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
2.	Exoran-1g Injection vial	P-252 P-251	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
3.	Exit 500mg injection	P-829 P-828	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).
4.	Exit 1g injection	P-1107 P-1106 P-1105 P-1104	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).

The details of Substandard water for injection ire as follows:

Sr. No.	Product Name	Batch No.	Manufacturers	Remarks
1.	Water for Injection	W-174	M/s City Pharmaceutical Laboratories, Plot 12-A, I-5, Sector 5, Korangi Industrial Area, Karachi (DML No. 00723).	The sample has been declared as “Substandard” based on presence of particles visible to naked eye.

Risk Statement:	TThese findings indicate a high public health risk, primarily affecting hospitalized patients and vulnerable groups. The most likely to be harmed are neonates, children, elderly patients, immunocompromised individuals, post-surgical patients, and those receiving IV therapy. Substandard Water for injection containing particles visible to the naked eye may cause bloodstream infections, septic or pyrogenic reactions, and potentially fatal complications. Particles may also contribute to embolic or inflammatory complications. The greatest risk is in intensive care, emergency, and other clinical settings where sterile injectable products are essential.
Action Initiated	The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
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 products along with the other drug products containing Water For Injection (Batch No.: W-174) are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information about 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 mentioned products along with the other drug products containing Water For Injection (Batch No.: W-174). The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).
Advice for Consumers	Consumers should stop using products bearing the affected batch number(s) and containing water for injection (Batch No.: W-174) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug products, and report the incident to Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre.

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.

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