Recall Alert
| DRAP Alert No | No I/S/09-24-36 |
| Action Date | 26th September 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) in Punjab has identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results. The Details of affected product batches are tabulated below:- |
Therapeutic Good(s) Affected: –
Human Use Products
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Painsa 75mg/3ml Injection Reg. No. 077269 | Diclofenac Sodium | PA415 | M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 02 | Metroin Infusion 100ml Reg.No 071279 | Metronidazole 500mg/100ml | MT24-058, MT24-060, MT24-061, MT24-062, MT24-063 | M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
Veterinary Use Products
| Sr. | Product Name | Composition | Batch No. | Manufactured by | Test Results |
|---|---|---|---|---|---|
| 03 | Oxytocin Injection Reg.No 019928 | Oxytocin 10 I.U/ml | V6-143 | M/s. ISIS Pharmaceutical & Chemical Works, Karachi. | Substandard |
| 04 | Selmec Injection 50ml Reg.No. 071087 | Ivermectin 20mg/ml | SN-113 | M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 05 | Rasomycin-10 Injection Reg.No. 003791 | Oxytetracyclin 100mg/ml | VJ. 1340 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 06 | Rasomycin LA 20% Injection Reg.No. 003791 | Oxytetracyclin 200mg/ml | VG. 1626 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 07 | Rasomycin-5 Injection Reg.No 003791 | Oxytetracyclin 50mg/ml | VK. 1467 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 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. |