117. Recall Alert (Class-II) – DTLs Punjab Declared Substandard Drug Products.

DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

DRAP Alert No	No I/S/12-25-117
Action Date	08 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories, Punjab 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.	Tablet Virtec 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg	FK-25-001	M/s Don Valley Pharmaceuticals (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000395)	The sample is Substandard on the for Organic Impurities, performed as per USP.
2.	Tablet Megadip 5mg Each Tablet Contains: Amlodipine as Besylate ….  5mg (Reg. # 32876)	25G337	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore. (DML # 000537)	The sample is declared as “Sub-Standard” on the basis of Test for Impurities (Organic Impurities).

Risk Statement:	The substandard quality of Tablet Virtec 10 mg (Cetirizine) and Tablet Megadip 5 mg (Amlodipine) due to failure in organic impurities testing poses a significant risk to public health. The populations most likely to be affected include patients suffering from allergies, hypertension, and cardiovascular diseases, particularly elderly individuals, children, and patients with chronic illnesses who regularly depend on these medicines for symptom control and disease management. The presence of excessive or unidentified organic impurities may lead to reduced therapeutic effect, unexpected side effects, toxic reactions, or long-term health complications. Continuous use of such substandard medicines may result in treatment failure, worsening of disease conditions, hospitalization, and in severe cases, life-threatening outcomes, thereby representing a serious public health concern.
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.