Recall Alert
| DRAP Alert No | No II/S/09-25-64 |
| Action Date | 15 September, 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 samples of below mentioned products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Tablet Ortizin 10mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 24L377 | M/s Obsons Pharmaceuticals. 209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416) | DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of assay and impurities testing. |
| 2. | Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 25B084 & 25B085 | M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore. (DML # 000537) | DDCP Alert No. l72/2025 declared the sample as ‘substandard’ on the basis of impurities testing (Organic impurities). |
| 3. | Tablet Ascard 75 Each enteric coated tablet contains: Acetyl Salicylic acid …. 75 mg | AR076K | M/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188) | DDCP Alert No. l73/2025 declared the sample as ‘substandard’ on the basis of test for related substance (Impurity C: Salicylic Acid). |
| 4. | Tablet Bytec 10mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | E604, E605 & E606 | M/s Batala Pharmaceuticals. 23/B Small Industrial Estate No. 2 Gujranwala. (DML # 000477) | DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing. |
| 5. | Tablet Vivin 10 mg Each film coated tablet contains: Cetirizine 2HCl ……10 mg | 315 | M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543) | DDCP Alert No. l79/2025 declared the sample as ‘substandard’ on the basis of impurities testing. |
| Risk Statement: | The above-mentioned batches of tablets have been declared substandard due to failure in assay and impurities testing, including elevated levels of related substances. Use of these defective medicines may lead to reduced therapeutic effect, unpredictable side effects, and potential toxicity. Patients, pharmacists, and healthcare providers are advised to discontinue the affected batches immediately and report any adverse events to DRAP. |
| 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. |