Recall Alert
| DRAP Alert No | No I/S/10-24-39 |
| Action Date | 25th October 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab. The Details of affected product batches are tabulated below:- |
Therapeutic Good(s) Affected: –
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Zonid Suspension 120ml Reg# 022579 | Metronidazole 200mg/5ml | Z266 | M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar. | Contains Ethylene Glycol Above Permissible limits |
| 02 | Hedazol Suspension 60ml Reg# 046146 | Metronidazole 200mg/5ml | 7037 | M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar. | -do- |
| 03 | Vometol Suspension 120ml Reg# 094719 | Domperidone 5mg/5ml | 1347 | M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar. | -do- |
| 04 | Tritadin Syrup 60ml Reg# 096413 | Loratadine 1mg/ml | 005 | M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad. | -do- |
| Action Initiated | –The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company. -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, by phone at +92 51 9255969, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance 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 products 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. |