RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-72
Action Date	18th 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.	Satafenac Injection.     Each 3mL contains: Diclofenac Sodium (В.Р) 75mg	DS25-152	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The Drug Testing Laboratory, Lahore has declared the product ‘substandard’ on the basis of ‘visible particulate matter’.
2.	Infusion METROIN 100ML Metronidazole 500mg/100ml	MT25-029 & MT25-083	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The Drug Testing Laboratory, Bahawalpur has declared the Batch # MT25-029 of product as ‘substandard’ on the basis of ‘Bacterial Endotoxin test. & The Drug Testing Laboratory, Lahore has declared the Batch # MT25-083 of product as ‘substandard’ on the basis of ‘Particulate contamination: visible particles’ & ‘sterility test’
3.	Aqua-P Injection Sterile water for injection 5ml	P-678	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	The Drug Testing Laboratory, Lahore has declared the product as ‘substandard’ on the basis of ‘visible particulate matter’ & ‘Bacterial endotoxin test’
4.	Injection Cara-Fer 5ml   Each ampoule (5ml) contains: iron sucrose complex eq. to elemental iron ………. 100mg (Reg # 052523)	24G001	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	The Drug Testing Laboratory Rawalpindi has declared the product as “Substandard” with respect to pH test, Turbidity test and Alkalinity test performed.

Risk Statement:	The defects identified include presence of visible particulate matter, bacterial endotoxin contamination, sterility failure, and particulate contamination. Use of such defective injectable products may pose serious health risks, including infection, sepsis, and adverse clinical complications, particularly in vulnerable patient populations. Healthcare professionals, distributors, and patients are strongly advised to stop the use of the above-mentioned batches immediately and follow DRAP’s recall and reporting procedures.
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.