02. Recall Alert (Class-II) – Drug Products tested by DTL Punjab

Salateen Philip Recall Alerts February 12, 2026February 12, 2026Recall

Recall Alert


	DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	N^oII/S/02-26-02
Action Date	12 Febraury, 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 Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	TABLET ASCARD-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin) 75mg (Reg # 016600)	AR065L, AR047L	M/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188)	The sample has been declared “Substandard” with respect to test performed for “Related Substances”
2.	Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine dihydrochloride USP 10mg (Reg # 032865)	24F213	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
3.	Tablet Sapizine 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)	13098	M/s Sapient Pharma. 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
4.	Tablet Rozen 10mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 040161)	5F006	M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)	The sample has been declared “Sub-Standard” with regards to Impurities Tests.
5.	Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt 1mg Neomycin in the form of sulphate 3500I.U (Reg # 012475)	17-54, C8-26	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (which is an undeclared active pharmaceutical ingredient not stated on the product label.

Risk Statement:	These products present a moderate to high public health risk, mainly affecting the general outpatient population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Substandard aspirin (Ascard-75) with excessive related substances may increase the risk of gastrointestinal irritation, bleeding, or reduced cardiovascular protection in patients using it for long-term prevention of heart attack or stroke. Multiple cetirizine brands failing impurity tests could expose the public—particularly children and individuals with liver or kidney compromise to unexpected toxic effects or reduced safety margins, even though the medicine is generally used for minor allergic conditions. The highest concern is Kanadex-N cream, where adulteration with an undeclared corticosteroid base can lead to misuse, skin thinning, hormonal suppression, masking of infections, and serious harm in infants or prolonged users, making dermatology patients and self-medicating consumers the most likely to be affected.
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.