Product Recalls – Page 2 – Drug Regulatory Authority of Pakistan

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.

27. Rapid Alert – Falsified IMFINZI Injection & ENHERTU 100mg

Salateen Philip Recall Alerts May 6, 2026May 6, 2026RapidAlert

Rapid Alert


	FALSIFIED IMFINZI® (Durvalumab) Injection 500mg/10ml & FALSIFIED ENHERTU® 100 mg

DRAP Alert No	N^o I/S/05-26-27
Action Date	06 May, 2026
Target Audience	Regulatory Field Force of DRAP and Provincial Drug Control Departments Healthcare Professionals Hospitals and Oncology Centers Consumers
Problem Statement	AstraZeneca Pakistan has notified DRAP regarding identification of suspected batches of falsified oncology products namely IMFINZI® (Durvalumab) Injection 500mg/10ml and ENHERTU® 100 mg, following authenticity queries raised by healthcare professionals from hospitals in Lahore, Pakistan. Investigations conducted by AstraZeneca and the respective manufacturers confirmed that the identified batches were not manufactured by the genuine manufacturers and are considered falsified products. The affected products and batches are as follows:

S #	Name of Product	Batch	Expiry Date	Purported Manufacturer	Remarks
1	IMFINZI® (Durvalumab) Injection 500mg/10ml	ASCB	08-2028	AstraZeneca, Sweden	Falsified
2	ENHERTU® 100 mg	DK1262	02-2026	Daiichi Sankyo / AstraZeneca	Falsified

Investigation Findings:	IMFINZI® 500mg/10ml AstraZeneca Sweden Operations confirmed that batch number ASCB was never issued/manufactured by the company. Comparative assessment revealed packaging inconsistencies resembling products referenced in WHO Medical Product Alert No. 5/2024 concerning falsified IMFINZI®. The product is intended for intravenous administration and poses a significant risk to patient safety. ENHERTU® 100 mg Manufacturer confirmed that batch number DK1262 has never been produced. Visual examination identified multiple discrepancies in labeling, serial numbering, printing alignment, barcode formatting, and carton artwork compared with genuine packs. Packaging characteristics were inconsistent with approved manufacturer specifications.
Risk Statement	IMFINZI® (Durvalumab) is an oncology medicine used in treatment of various cancers, while ENHERTU® is indicated for HER2-positive malignancies. Use of falsified oncology products may result in: Therapeutic failure Disease progression Delay in life-saving cancer treatment Serious adverse reactions due to unknown composition Potential fatal consequences Since both products are administered intravenously, the public health risk associated with these falsified products is assessed as critical/high.
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 mentioned batches of these drug products 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.

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.

22. Recall Alert – Drug Products declared substandard by Provincial laboratories.

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/03-26-22
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 of Punjab Province 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.	Injection. Cara-Doba Each 5 ml ampoule contains: Dobutamine HCl USP eq to Dobutamine … 250 mg (Reg # 054987)	26A037 & 25J016	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 Visible Particulates in Injections and Assay Test.
2.	EPHASEF 1G Powder for Injection Each Vial contains: 1g Sterile Cephradine U.S.P. (Reg # 044343)	EM073	M/s E-Pharm Laboratories. A-40 S.I.T.E Super Highway North Karachi (DML # 000598)	The sample is Sub-Standard with regards to Sterility test.
3.	IPROLAC Injection 30mg/mL Each 1mL contains: Ketorolac Tromethamine ….30mg ( Reg # 112065)	25L048	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	The above sample is SUB-STANDARD, on the basis of Sterility test performed as per USP, and MISBRANDED on the basis of The Drugs Act, 1976, 3 (s) (iv). Product label bears, product specs: whereas monograph of exists in USP 2025, which manufacturer failed to provide is “Ketorolac specifications” from registration board. not Innovator’s Tromethamine Specifications prescribed on the approval letter of injection” label, and “Innovator’s
4.	Injection Metiver Each 1ml ampoule contains: Mecobalamin…….500mcg (Reg # 098031)	25J438	M/s Iqra Pharmaceuticals. Plot No. 2, Street No. S-9, RCCI, Rawat (DML # 000899)	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).
5.	MECOJIN Injection Each Ampoule contains: Mecobalamin JP ……500mcg (Reg. # 124090)	25A082	M/s Islam Pharmaceuticals. 7KM, Pasrur Road, Sialkot (DML # 000885)	The sample is declared as “Adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
6.	Sporex Injection 50ml Each Vial Contains: Sterile Powder of Ceftriaxone Sodium USP eq. to Ceftriaxone 250mg (Reg. # 055202)	98101	M/s Raazee Therapeutics (Pvt) Ltd. 48-Km Lahore Kasur Road Kasur. (DML # 000437)	The sample is Sub-Standard with regards to Sterility.
7.	Neocobal Injection 0.5 mg/ml Each 1ml ampoule contains: Mecobalamin…….500mcg (Reg # 071447)	S-2988	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).
8.	Sidofenac Injection Each 3 ml contains Diclofenac Sodium 75 mg (Reg # 086452)	DI0016	M/s N.S Pharma. Plot No. 576-577, Sunder Industrial Estate, Lahore. (DML # 000869)	The sample is Sub-Standard with regards to Description (Visible Particulates In Injections).
9.	Injection Hicobal Each Ampoule contains: Mecobalamin JP ……500mcg (Reg # 032320)	HT13437	M/s Himont Pharmaceuticals (Pvt) Ltd. 17-Km Ferozepur Road Lahore. (DML # 000231)	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).

Risk Statement:	The use of these substandard, adulterated, and misbranded injectable products poses serious health risks, including treatment failure, severe infections, hypersensitivity reactions, and potential life-threatening complications due to lack of sterility, incorrect active ingredients, or presence of particulate matter. Patients receiving critical care, antibiotics, pain management, or vitamin B12 therapy may experience worsening of their medical condition or unexpected adverse effects. Hospitalized patients, individuals receiving injectable antibiotics, cardiac support drugs, pain management injections, and patients treated for Vitamin B12 deficiency particularly those in intensive care units, emergency settings, and immunocompromised populations.
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.

21. Rapid Alert – SPURIOUS Nandrolone Injection 100mg/ml

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

Rapid Alert


	SPURIOUS Nandrolone Injection 100mg/ml

DRAP Alert No	N^o I/S/04-26-21
Action Date	14 April, 2026
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug Testing Laboratory (DTL), Government of Punjab has reported that the sample of the following drug product has been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.

S#	Product Name	Batch	Manufacturer	Remarks
1	Deka-Duralin Injection 100 mg/ml (Nandrolone Decanoate) Reg. No. 074187	H-191	*Purported to be manufactured by* Hansel Pharmaceuticals (Pvt.) Ltd., Lahore	Declared Spurious, API not identified; assay 0%; fails identification test

Risk Statement	Use of this spurious injectable product may result in complete therapeutic failure and may expose patients to serious health risks, particularly in conditions requiring anabolic steroid therapy.
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 these products 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.

20. Rapid Alert – SPURIOUS DYDROGESTERONE TABLETS

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

Rapid Alert


	SPURIOUS DYDROGESTERONE TABLETS

DRAP Alert No	N^o I/S/04-26-20
Action Date	14 April, 2026
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug Testing Laboratory (DTL), Government of Punjab has reported that the samples of the following drug products have been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.

S#	Product Name	Batch	Manufacturer	Remarks
1	Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg	DRP-0011	Purported to be manufactured under M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.
2	Efaston Tablets 10 mg (Dydrogesterone)	4116	Purported to be manufactured under M/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064).	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.
3	Depasrone Tablets Each Tablet contains Dydrogesterone 10mg	2648	Purported to be manufactured under M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi	Declared Spurious (API not detected, assay 0%, fails identification & dissolution.

Risk Statement	(Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health.
Action Initiated	The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 these products 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.