Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB. |
| DRAP Alert No | No I/S/03-26-23 |
| Action Date | 14 April, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories informed that the samples of below mentioned drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Remarks |
| 1. | Tablet Nitras Each sustained release tablet contains: Glycerin Trinitrate …. 2.6 mg (Reg # 056007) | 24L069 | M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629) | The Sample is declared as “sub-standard” on the basis of Assay & Dissolution Test. |
| 2. | Tablet Kadin 2 mg Each Tablet Contains: Tizanidine (as Hydrochloride) …… 2mg (Reg # 033347) | 569 | M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494) | The sample is declared as “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Paracetamol identified). |
| 3. | Tablet Loratamin Each Film Coated Tablet Contains: Loratadine USP 10mg (Reg # 062647) | 24 | M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543) | The above sample is adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Paracetamol. |
| 4. | ACEFYL COUGH SYRUP Each 5mL contains: Acefylline Piperazine….45mg, Diphenhydramine HCl…8mg (Reg # 023394) | ACH479 | M/s NABIQASIM INDUSTRIES (PVT.) LTD., 17/24, Korangi Industrial Area, Karachi. (DML # 000105). | The above sample is ADULTERATED as per The Drugs Act 1976, 3 {a (i)} (The one unit of sample contains a glass piece in it). |
| 5. | Tablet ORTIZIN/10mg Each film coated tablet contains. Cetirizine dihydrochloride U.S.P 10 mg (Reg # 025405) | 25F135 | M/s Obsons Pharmaceuticals. 209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416) | The sample is declared as “SUB-STANDARD” on the basis of Assay Test and Test for Impurities (Organic Impurities). |
| Risk Statement: | The use of these substandard and adulterated oral products may result in reduced therapeutic efficacy, unexpected adverse drug reactions, and serious safety concerns due to incorrect active ingredients, contamination (including glass particles), and failure to meet quality standards. This may lead to inadequate disease control, allergic reactions, or physical injury to patients. Patients using these medicines for cardiac conditions, allergies, muscle spasm, and cough particularly children, elderly individuals, and those with chronic illnesses who rely on consistent and safe oral medication therapy. |
| 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. |