Rapid Alert
Urgent Recall of Suspected Product for contamination of DEG / EG
| DRAP Alert No | NoI/S/02-23-8 |
| Action Date | 20th February 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Bromgen Syp 100mL (Reg. Export Only) | Bromhexine HCl | L392 | M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan |
| 2 | Kof Relief Syp 100mL (Reg, Export Only) | Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour | L394 | -do- |
| 3 | Macofen Syp 100mL (Reg, Export Only) | Ibuprofen | L395 | -do- |
| 4 | Vomitil Suspension 120mL (Reg, Export Only) | Domperidone | L400, L408, L414, | -do- |
| 5 | Asperfin Syp 60mL | Ketotifen | L401 | -do |
| 6 | Davis Tonic Syrup (250mL, 120ml) | Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate | CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159 | -do- |
| 7 | Zinc Syp 60mL | Zinc Sulphate Monohydrate | CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93 | -do- |
| Action Initiated | The manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |