Recall Alert – Drug Products declared substandard

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/10-25-86
Action Date	09th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Departments 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.	Tablet Rolekast 10mg   Each film coated tablet contains: Montelukast (as Sodium)…10 mg	1397	M/s Roryan Pharmaceutical industries (Pvt) Ltd. 85-B Hayatabad Industrial Estate Peshawar.  (DML # 000566)	The sample is declared as “Sub-Standard” on the basis of Dissolution Test and impurities test.
2.	AME-CLOP Injection Each 2mL contains: Metoclopramide HCL….10mg	MC-126	M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604)	sample is ‘Sub-Standard’ on the basis “Particulate contamination: visible particles” as per BP.
3.	Infusion DORCIP Each ml contains: Ciprofloxacin (as Lactate)….2mg	DC-120	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Sub-Standard” on the basis of Visible Particulates, pH Test, Sterility Test and Bacterial Endotoxin Test (BEТ).

Risk Statement:	Tablet Rolekast 10 mg (Batch 1397), used for asthma and allergic rhinitis in children and adults, has failed dissolution and impurity tests. AME-CLOP Injection (Batch MC-126), used for severe nausea, vomiting and gastrointestinal disorders in patients including pregnant women, surgical and chemotherapy cases, contains visible particles posing risk of embolism and infection and DORCIP Infusion (Batch DC-120), used in serious infections among adults and  critically ill patients, failed sterility, endotoxin and pH tests, risking sepsis and life-threatening reactions. Use of these defective medicines can cause ineffective treatment, adverse reactions, and serious safety hazards. Healthcare providers and distributors must immediately stop use and sale, quarantine affected stock, and return it to the supplier, while patients should discontinue these batches and seek medical advice if exposed.
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.