RECALL ALERT – Class I – Substandard drug Products

PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No I/S/09-25-76
Action Date	23 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Aqua-P Injection Sterile water for injection 5ml	P-679	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	‘Sub-standard’ on the basis of “Visible particulate matter” as per USP.
3.	Neocobal Injection 0.5 mg Each ml contains: Mecobalamin.0.5 mg	S-2705	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	‘Substandard’ with regards to Assay and ‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.
4.	Kanadex-N Cream   Each gram contains: 1 mg of dexamethasone-21 phosphate in the form of disodium salt U.S.P. 3500 i.u. of Neomycin in the form of Sulphate U.S.P.)	F7-27	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	‘Substandard’ with regards to Assay of Dexamethasone Phosphate and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
5.	Remedy Injection 500 mcg   Each 1ml ampoule contains: 500mcg of Mecobalamin	R-2419	M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)	‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The presence of visible particles, failed assays, incorrect active ingredient levels, and adulteration with undeclared or unsafe components renders these medicines unsafe, ineffective, and potentially harmful to patients. Their use may result in treatment failure, unpredictable adverse effects, and serious safety risks including allergic reactions, infections, or toxicity.
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.