Recall Alert
| DRAP Alert No | No I/S/01-24-05 |
| Action Date | 30th January 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public |
| Problem / Issue | Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer | Test Results |
|---|---|---|---|---|
| Asthanil 60ml Syp | Ketotifen 1mg/5ml | 03-23 | M/s. Siza International (Pvt.) Ltd 18-Km Ferozpur Road, Lahore. | Ethylene Glycol: 2.896% Does not comply |
| Virol Syrup | Ribavirin 5mg/5ml | 35080 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 3.31% Does not comply |
| Torax DM Syrup | Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg | 110-23 | M/s. Siza International (Pvt.) Ltd., 18-Km Ferozpur Road, Lahore. | Ethylene Glycol: 2.14% Does not comply |
| Texcol EX Syrup | Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg | 63833 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 0.985% Does not comply |
| Texcol DM Syrup | Dextromethorphan HBr 10mg/5ml | 09953 | M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore. | Ethylene Glycol: 1.19% Does not comply |
| Allerphene Syrup | Chloepheniramine Maleate 2mg/5ml | 3002 | M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore. | Ethylene Glycol: 1.417% Does not comply |
| Speczine Syrup | Promethazine HCl 5mg/5ml | 276 | M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore. | Ethylene Glycol: 2.43% Does not comply |
| Bronyl syrup | Nutraceutical cough preparation | BL-013 | M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore. | Ethylene Glycol: 0.12% Does not comply |
| Action Initiated | -All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). -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 through phone at +92 51 910 73 17, 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 this 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. |