Recall Alert
| DRAP Alert No | No I/S/06-25-50 |
| Action Date | 23rd June, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Medistil Injection Reg. No. 064758 | Sterile Water for Injection……5ml | 25L608 | M/s. Medisave Pharmaceuticals, 578-579, Sundar Industrial Estate, Lahore. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| Kanadex-N Cream Reg. No. 012475 | Each gram contains: Dexamethasone-21 phosphate as disodium salt…….1mg Neomycin as sulphate…3500 i.u. | F7-27 | M/s ISIS Pharmaceuticals & Chemical Works, 25/1-3, Sector 12-C, North Karachi Industrial Area, Karachi. | ‘Substandard’ on the basis of Assay of Dexamethasone phosphate. |
| Bytec Tablet 10mg Reg. No. 036183 | Each Film coated tablet contains: Cetirzine dihydrochloride…..10mg | E090 | M/s Batala Pharmaceuticals., 23/B Small Industrial Estate #2, Gujranwala. | ‘Substandard’ on the basis of Impurities test. |
| Sterile Water for Injection 5ml Reg. No. 071329 | Sterile Water for Injection….5ml | 25WF01 | M/s Friends Pharma (Pvt) Ltd., 31-Km, Ferozpur Road, Lahore. | ‘Substandard’ with regards to visible particulates in injection. |
| Cetfin 10mg Tablet Reg. No. 091843 | Each film coated tablet contains: Cetirizine dihydrochloride ..…..10mg | CT67 | M/s. Effort Pharmaceuticals (Pvt.) Ltd, 28-Km, Ferozpur Road, Lahore. | ‘Substandard’ on the basis of Test for impurities (Organic impurities). |
| Kanabax Cream 15g Reg. No. 070880 | Each gram contains: Dexamethasone….1mg Neomycin Sulphate….3.5mg | KNX-270 | M/s. Baxter Pharmaceuticals, A-1/A, Phase 1, S.I.T.E., Super Highway, Karachi. | ‘Misbranded’ with regards to Labeling as per Section 3(s)(iv), ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976, and ‘Substandard’ on the basis of Assay of Neomycin and Dexamethasone Phosphate. |
| Surgitex Latex Surgical Gloves (powdered) Reg. No. MDIR-0001236 | Surgitex Latex Surgical Gloves Size 7.0 Powdered Sterile | 20241001 | Manufactured by: Suzhou Colour-way New Material Co., Ltd, 20 Anmin Road, Huangdai Town, Xiangcheng District 215152, Suzhou, China. Marketed by: M/s Al-Hamd Enterprises FL-11/1/1, Block-6, Gulshan-e Iqbal, Karachi. | ‘Substandard’ with regards to Sterility Test. |
| Risk Statement: | The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population. |
| 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 the information 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 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. |