105. Recall Alert – Drug Products for Human Use Declared Substandard

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/10-25-105
Action Date	30 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 Nidagyl 100ml Metronidazole…500mg/100ml (Reg # 020601)	HM 139	M/s Star Laboratories (Pvt) Ltd. (Human Healthcare Division), 23 Km Multan Road Lahore. (DML # 000130)	The sample is declared as “Adulterated”
2.	Myteka Sachet Each Sachet contains: Montelukast (as sodium) … 4mg (Reg. # 039427)	155321	M/s Hilton Pharma (Pvt) Ltd.   Plot No. 13 & 14 Sector 15 Korangi Industrial Area Karachi. (DML # 000136)	The sample is Sub-Standard on the basis of Impurities Test.
3.	Sterile Water for Injection Water for injection 5ml	WI-132	M/s FYNK Pharmaceuticals.  19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494)	The Sample is Sub-Standard on the basis “Visible particulate matter” as per USP.

Risk Statement:	The use of these defective human drug products poses potential health risks to patients. Injection Nidagyl (Batch HM 139), declared adulterated, may cause treatment failure or toxic reactions in patients receiving parenteral therapy for infections. Myteka Sachet (Batch 155321), found sub-standard due to impurities, may lead to reduced efficacy or adverse effects in pediatric and asthmatic patients commonly using Montelukast. Sterile Water for Injection (Batch WI-132), declared sub-standard due to visible particulate matter, poses a serious risk of embolism or infection in patients where sterility is critical, particularly neonates, elderly, and hospitalized patients.
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.