94. Recall Alert (Class-II) – Substandard Drug Products.

DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No II/S/10-25-94
Action Date	16th October, 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 sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Kanabax Cream 15gm Each Gram contains: Dexamethasone ………… 1mg Neomycin sulphate ……… 3.5mg	KNX-272	M/s Baxter Pharmaceuticals. A-1/A Scheme No. 33 Phase-I S.I.T.E. Super Highway Karachi. (DML # 000700)	The sample is declared as “misbranded” with regards Labelling as per Section 3(s)(iv), ‘adulterated’ with regards to Section 3(a)(iv) of the Drugs Act,1976 & ‘substandard’ on the basis of Assay of Dexamethasone Phosphate.
2.	Zysic Tablet 10 mg Each film coated tablet contains: Cetirizine HCI (USP) … 10mg	727	M/s Jinnah Pharmaceuticals (Pvt) Ltd. 13-Km Lahore Road Multan. (DML # 000578)	‘Sub-Standard’ with regards to Impurities Test.

Risk Statement:	Use of Kanabax Cream (Batch No. KNX-272), declared misbranded, adulterated, and substandard, may lead to ineffective treatment, worsening of skin infections, or antimicrobial resistance, particularly in children and patients with chronic skin conditions. Similarly, Zysic Tablet 10 mg (Batch No. 727), found substandard due to impurities, may cause reduced efficacy or mild adverse effects in allergic or asthmatic individuals. Consumers are advised to avoid these batches and seek medical advice if already used.
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.