Recall Alert
| DRAP Alert No | No I/S/09-24-34 |
| Action Date | 23rd September 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Provincial Drug Inspector, Dera Ismail Khan, KPK collected the samples of Promass 1g Infusion and sent for analysis. The provincial Drug Testing Laboratory, KPK, Peshawar has declared batch No 034 of Promass 11g Inf, manufactured by the M/s Treat Pharmaceutical Industry, Bannu, as a substandard product. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Promass 1gm/100ml Inf Reg.No. 075336 | Paracetamol | Batch No. 034 Mfg Date:01-07-2023 Exp Date:30-06-2025 | M/s. Treat Pharmaceutical Industry (Pvt.) Ltd, Kohat Road, Bannu |
| Risk Statement: | Identification of visible particles in infusion products is a serious indicator of substandard quality, which can lead to significant health risks including severe reactions such as shivering, high fever, arterial blockages, infarction and more serious adverse events. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased 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 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 these 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. |