Rapid Alert
| DRAP Alert No | No I/S/12-24-56 |
| Action Date | 31st December, 2024 |
| Target Audience | 1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under: |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| S-KYNE Film Coated Tablet (Dydrogesterone 10mg) Reg# 100245 | 566 | – | – | Purported to be manufactured by Weather Fold Pharmaceuticals, 69/2 Phase-II, Industrial Area, Hattar | Spurious and Misbranded |
| MY-RON film coated tablet (Dydrogesterone 10mg) Reg# 119670 | MYR-001 | – | – | Purported to be manufactured by Piriv Pharmaceutical, (Fictitious firm), 69-Km, Multan Road, Lahore | Spurious |
| Syrup Carenol 60ml (Ammonium Chloride 125mg, Sodium Citrate 55mg, Chlorpheniramine Maleate 205mg/5ml) Reg# 026907 | CL-037 | – | – | Purported to be manufactured by Well Care Pharmaceuticals, A/7, P.S.I.E, Sargodha | Spurious and Misbranded |
| Syrup Histacare 450ml (Chlorphineramine Maleate) 2mg/5ml Reg# 066498 | HE-036 | – | – | Purported to be manufactured by Well Care Pharmaceuticals, A/7, P.S.I.E, Sargodha | Spurious |
| Syrup Trylac 120 mL (Lactulose 66.7g/100 mL) Reg# 0543511 | TL-113 | – | – | Purported to be manufactured by Torrent Pharmaceuticals (Fictitious Firm) G-19, Hawkes Bay Road, SITE, Karachi | Spurious and Misbranded |
| Capsule Emmox 500 mg (Amoxicillin 500mg) Reg# 9440494 | 010527 | – | – | Purported to be manufactured by Milpharma Int’l Ltd, (Fictitious Firm) D-40 Karachi | Spurious |
| Vital Wal injection 100ml (Vit. A 60000IU, Vit. D3 40000IU, Vit. E 20mg) Reg# 000735) | 1-109 | – | – | Purported to be manufactured by Nawal Pharmaceuticals, Plot No. 11-A, Punjab Small Industrial Estate, Taxila | Spurious |
| Action Initiated | All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying the 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). DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of the mentioned products. Adverse reactions or quality problems experienced with the use of these products are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. |
| Advice for Therapeutic Goods Manufacturers | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from the same lot of propylene glycol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from 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. |