103. Recall Alert – Drug Products Declared Substandard.

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/10-25-103
Action Date	28 October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory from Province informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection Remedy Mecobalamin: 500mcg/ml (Reg. # 040385)	R-2411 & R-2419	M/s Pak Risen Pharmaceuticals Plot No. 3, Block B, Phase I – II, Industrial Estate Hattar. (DML # 000573)	The sample is declared as “Sub-Standard” on the basis of Assay Test & “Adulterated” on the basis of identifying Cyanocobalamin (9.7 mcg/ml).
2.	Injection Neocobal Mecobalamin: 0.5 mg/ML (Reg. # 071447)	S-2825	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” on the basis of identifying Cyanocobalamin (0.106 mg/ml).

Risk Statement:	Administration of these defective injections may result in therapeutic failure, delayed neurological recovery, or persistence of deficiency symptoms, particularly among diabetic, anemic, elderly, and neuropathic patients who rely on Mecobalamin therapy for nerve regeneration and metabolic balance. In severe cases, the presence of unintended forms of Vitamin B12 (Cyanocobalamin) may lead to altered metabolic response or unexpected adverse effects in patients with impaired renal or hepatic function.
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.