113. Recall Alert (Class-I) – Substandard Drug Products (Human)

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	No I/S/11-25-113
Action Date	20 November, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Drug Testing Laboratories informed that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection Freclomide Each Ampoule contains Metoclopramide HCl ……10mg (Reg. # 071331)	25MC09	M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000531)	The above sample is Sub-Standard on the basis of “Particulate contamination: visible particles” performed as per BР.
2.	Infusion SAFEMED Each 100ml contains: Metronidazole ……….. 500mg (Reg. # 045824)	SAU-2501	M/s Ahad International Pharmaceutical Limited. 13-Km Gomal University Multan Road Dera Ismail Khan. (DML # 000433)	The above sample is Sub-Standard, on the basis of Particulate contamination: visible particles performed as per BP.
3.	Tablet Loratamin Each Tablet Contains: Loratadine …. 10mg (Reg. #  062647)	23	M/s Murfy Pharmaceuticals (Pvt) Ltd.  8-Km Raiwind Road Lahore. (DML # 000543)	The sample is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains “Paracetarmol” as an ingredient a substance other than the prescribed substance i.e., Loratadine.

Risk Statement:	All three products present a high public health risk due to critical quality defects. Injection Freclomide and Infusion SAFEMED contain visible particulate contamination, which can lead to severe reactions such as embolism, sepsis, organ damage, or death, especially when administered intravenously. Tablet Loratamin is adulterated with Paracetamol, exposing patients to incorrect therapy, potential allergic reactions, and failure to treat the intended condition. The population most likely to be affected includes acutely ill patients in hospitals, emergency departments, and general public using these medicines for routine treatment, placing them at a heightened risk of adverse outcomes due to compromised product quality.
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.