131. Recall Alert (Class-II) – DTLs Punjab Declared Substandard products.

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	No II/S/01-26-131
Action Date	14 January, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories of Provinces informed 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. Megadip Each tablel contains: Amlodipine as Besylate USP…. 5mg (Reg. # 071447)	25F278	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)	The samples have been declared Sub-standard with regards to Impurities test.
2.	Tablet Ascard 75 mg Each Enteric Coated Tablet contains: Aspirin 75 mg (Reg # 016600)	AR049L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	The samples have been declared Sub-standard with regards to Test for Related substances (Impurity C: Salicylic Acid).
4.	Tablet CENEX 10 mg Cetirizine dihydrochloride 10mg (Reg # 032103)	422	M/s Dr. Raza Pharma.  Road B-4 P.No 44-C Indus: Estate Jamrud Road Peshawar. (DML # 000387)	The sample is declared as “Sub-Standard” on the basis of test for Impurities i.e. Organic Impurities.
5.	Tablet Valron-P Each Sugar Coated Tablet contains: Diclofenac Sodium …. 50 mg (Reg # 030760)	T-03624	M/s Venus Pharma.   23 Km Multan Road Lahore. (DML # 000300)	The sample is declared as “Sub-Standard” on the basis of Disintegration and Dissolution Test.

Risk Statement:	The presence of excessive impurities, toxic contaminants, and performance failures in Megadip (amlodipine), Ascard (aspirin), Entagyl suspension (metronidazole), Cenex (cetirizine), and Valron-P (diclofenac) poses a significant risk to patient safety. Elevated levels of impurities, including salicylic acid, organic impurities, and ethylene glycol, may lead to toxicity, organ damage, allergic reactions, and gastrointestinal or neurological complications, while poor disintegration and dissolution can cause treatment failure or unpredictable dosing. The public most likely to be affected includes patients with heart disease, hypertension, infections, allergies, and chronic pain, particularly elderly patients, children, and those with kidney, liver, or cardiovascular disorders, where compromised medicine quality may result in serious and potentially life-threatening outcomes.
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.