DRAP recall ⚠️Substandard Medicines⚕️-27 June-2025
The Directorate of Drug Control (DDC) Punjab has notify DRAP (drug regulatory authority of Pakistan) that the samples of following batches of below mentioned medicines have been declared as ‘Substandard’ via provincial drug testing laboratories.
| Product Name | Details | Reason for Substandard/Misbranded |
|---|---|---|
| Medistil Injection Reg. No. 064758 | Sterile Water for Injection 5ml Batch: 25L608 Manufacturer: M/s. Medisave, 578-579 Pharmaceuticals, Sundar Industrial Estate, Lahore | Substandard – Bacterial Endotoxin Test |
| Kanadex-N Cream Reg. No. 012475 | Each gram contains: Dexamethasone-21 phosphate as disodium salt…1mg and Neomycin sulphate 3500 I.U Batch: F7-27 Manufacturer: M/s ISIS Pharmaceuticals & Chemical Works,25/1-3, Sector 12-C, North Karachi Industrial Area, Karachi | Substandard – Assay of Dexamethasone phosphate |
| Bytec Tablet 10mg Reg. No. 036183 | Cetirizine dihydrochloride 10mg Batch: E090 Manufacturer: M/s Batala Pharmaceuticals, 23/B Small Industrial Estate #2, Gujranwala | Substandard – Impurities test |
| Sterile Water for Injection 5ml Reg. No. 071329 | Sterile Water for Injection 5ml Batch:25WF01 Manufacturer: M/s Friends Pharma (Pvt) Ltd, 31-Km, Ferozpur Road, Lahore | Substandard – Visible particulates |
| Cetfin 10mg Tablet Reg. No. 091843 | Cetirizine dihydrochloride 10mg Batch:CT67 Manufacturer: M/s. Effort Pharmaceuticals (Pvt.) Ltd, 28-Km, Ferozpur Road,Lahore | Substandard – Organic impurities test |
| Kanabax Cream 15g Reg. No. 070880 | Dexamethasone 1mg + Neomycin Sulphate 3.5mg/g Batch: KNX-270 Manufacturer: M/s. Baxter Pharmaceuticals, A-1/A, Phase 1, S.I.T.E., Super Highway, Karachi | Misbranded – Labeling issue (Sec 3(s)(iv)) Adulterated – (Sec 3(a)(iv)) of Drug Act 1976 Substandard – Assay of Neomycin & Dexamethasone |
| Surgitex Latex Surgical Gloves (Powdered) Reg. No. MDIR-0001236 | Size 7.0 Powdered Sterile Batch: 20241001 Manufacturer: Suzhou Colour-way New Material Co., Ltd, China Marketed by: M/s Al-Hamd Enterprises, FL-11/1/1, Block-6, Gulshan-e Iqbal Karachi | Substandard – Sterility Test |
👩💼Directions for Regulatory department regarding DRAP recall:
DRAP’s regulatory field force & Provincial Drug Control departments have been directed to instantly conduct market surveys for detection and removal of these products from the market.
🧑⚕️Direction for the Pharmacists & Chemists regarding DRAP recall:
All pharmacists and chemists working at distributors and pharmacies are directed to immediately check their stocks and stop supplying the above mentioned defective batches of the products. The remaining stocks should be separated, and the data of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.
Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP via filling out this form, or by Email at gsms@dra.gov.pk.
👩⚕️Direction for the Health Care Professional DRAP recall:
Health care professional are direction to be alert regarding the above mentioned products and improve vigilance especially in the the supply chains of institutions/pharmacies/healthcare facilities which are at high risk to be affected by the above mentioned defective batch of the products and report any adverse effect via Vigimobile App
🙍♂️Directions to the consumers regarding DRAP recall:
All the consumers of these products are advised to stop using above-mentioned products and contact their health care provider or doctors, in case of any adverse effect in relation to these products.
Reference:
Drug Regulatory Authority of Pakistan. (2025). Recall alert: Products declared substandard by provincial drug testing laboratories. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-products-declared-substandard-by-provincial-drug-testing-laboratories-5/
