Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts April 11, 2025April 11, 2025

Recall Alert

DRAP Alert No	N^oI/S/04-25-35
Action Date	07^th April, 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

Product Names	Composition	Batch Details	Manufactured by	Test Results
Amekoran Injection Reg. No. 053627	Each 2mL contains: Amikacin (as Sulphate).…250mg	BK-019	M/s Ameer Pharma (Pvt) Ltd, 23-Km, Sheikhupura Road, Lahore.	‘Substandard’ on the basis of visible particulates.
Ortizin Tablet Reg. No. 025405	Each film coated tablet contains: Cetirizine dihydrochloride.…10mg	24I268	M/s. Obsons Pharmaceuticals, 209-S, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.	‘Substandard’ with regards to impurities.
AQUA-P Injection Reg. No. 034290	Sterile water for Injection 5ml	P-669	M/s. IPRAM International, Plot No. 26, St # S.S-3, National Industrial Zone, Rawat.	‘Substandard’ on the basis of visible particulate matter.
Injection Dorcip 100ml Reg. No. 046086	Ciprofloxacin as lactate….2mg/ml	DC-121	M/s. Trigon Pharmaceuticals (Pvt) Ltd. 8-Km, Thokar Raiwind Road, Lahore.	‘Substandard’ with regards to visible particulates in injection and Sterility Test.
Meclomine Tablet 500mcg Reg. No. 042601	Each film coated tablet contains: Mecobalamine…500mcg	8482	M/s Alfalah Pharma (PVT) Ltd., 12-Km, Sheikhupura Road, Lahore.	‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Meclomine Tablet 500mcg Reg. No. 042601	Each film coated tablet contains: Mecobalamine…500mcg	8440	M/s Alfalah Pharma (PVT) Ltd., 12-Km, Sheikhupura Road, Lahore.	‘Substandard’ on the basis ofPhysical Description & Assay Testand ‘Adulterated’ as per section 3(a)(iv) of Drugs Act, 1976.
Injection Neocobal Reg. No. 042601	Mecobalamine 0.5mg/ml	S-2455	M/s Pulse Pharmaceuticals (Pvt.) Ltd., Sua Aasil, Raiwind Road, Lahore.	‘Substandard’ on the basis ofAssay Testand ‘Adulterated’ as per Drugs Act, 1976.

Risk Statement:	The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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 the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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.

Risk Statement:	The use of substandard veterinary product can result in therapy failure, increasing the risk of complications and potentially contribute to the development of drug resistance
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 the mentioned batch of the product from the market.
Advice for Veterinarians	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. -Please click here for further information on problem reporting to DRAP.
Advice for Farmers/ Consumers	Farmers/consumers should not use this product. They shall contact their veterinarians or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

Product Names	Composition	Batch Details	Manufactured by
Tablet AMLOShine 5mg Reg. No. 062420	Each tablet contains: Amlodipine as besylate…5mg	7974	M/s Sunshine Pharmaceuticals, Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala
Powder for Inj. Tyclan Reg. No. 087923	Each vial contains: Teicoplanin B.P….400mg	TL-011	M/s. MTI Medical (Pvt) Ltd, 586-587, Sundar Industrial Estate, Lahore.
Injection Linco-HCL Reg. No. 023729	Each 2ml ampoule contains: Lincomycin as HCl….600mg	LN-042	M/s. Trigon Pharmaceuticals (Pvt) Ltd. 8-Km, Thokar Raiwind Road, Lahore.
Safemed Infusion Reg. No. 045824	Each 100ml vial contains: Metronidazole…500mg	SJU-1724	M/s. Ahad International Pharmaceuticals Ltd. 13-Km, Gomal University, Multan Road Dera Ismail Khan.
Ketamine hydrochloride Injection Reg. No. NA	Each ml contains: Ketamine hydrochloride eq. to ketamine …50mg	GN1359	M/s KWALITY Pharmaceuticals Ltd., Nag kalan, Majitha Road, Amristsar 143 601 (India).

DRAP Alert No	N^oI/S/03-25-32
Action Date	15th March, 2025
Target Audience	1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals
Problem Statement	Directorate Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan vide test/analysis report No. 141002343, wherein the sample of Propylene Glycol (Raw Material) has been declared *‘Substandard’*. The falsified excipient was detected in the unregulated supply chain marketed through Facebook page and tested by Drug Testing Laboratory (DTL), Lahore. The contaminated propylene glycol batch (YFO1210911) was purported to be manufactured by Dongying Hi-Tech Spring Chemical Industry China. The results of test have revealed that the level of EG in the batch was 91.4%, far exceeding the accepted criteria of 0.1%. Details of test/analysis report are tabulated as under:

Product	Batch No*	Mfg Date	Exp. Date	Manufacturer Name (as per label)	Remarks
Propylene Glycol (Raw material)	YFO1210911	01-2024	01-2026	M/s. Dongying Hi-Tech Spring Chemical Industry Co Ltd, China	The sample is declared substandard due to conatmination of Ethylene Glycol.

Risk Statement	Di-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action Initiated	The Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
Advice for Therapeutic Goods Manufacturers	Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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.

Drug Regulatory Authority of Pakistan

Safety Info

Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

Recall Alert

Therapeutic Goods (s) Affected: –

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Therapeutic Goods (s) Affected: –

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Therapeutic Goods (s) Affected: –

Reports of serious adverse reactions with Ceftriaxone injection due to
unintentional mixing during reconstitution.

Safety Alert of Risk of Medication Errors resulting due to inadvertent intrathecal Tranexamic Acid Injection

Rapid Alert: CONTAMINATED PROPYLENE GLYCOL (BATCH # YFO1210911) PURPOTEDLY MANUFACTURED BY M/S. DONGYING HI-TECH SPRING CHEMICAL INDUSTRY CO LTD, CHINA.

Rapid Alert

Therapeutic Good Affected:-