Recall Alert
| DRAP Alert No | No II/S/08-23-32 |
| Action Date | 18th Sep, 2023 |
| Target Audience | · Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Pedolil 250mg/5mL Suspension Reg No. 110389 | Paracetamol (Acetaminophen) | Batch No 167 Mfg. date 05.2023 Exp. date 04.2025 | Ms. JASM Pharmaceutical (Pvt.) Ltd., Risalpur |
| Risk Statement: | Paracetamol suspension is used for mild to moderate pain and fever. Inaccurate use of the product may lead to adverse reactions including but not limited to following: · Blood disorders, such as thrombocytopenia and leukopenia. · Liver and kidney damage. Impact of use of substandard product on basis of deliverable volume may leads to non- uniformity of dose and may alter therapeutic effect. |
| 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 product. 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) should also increase 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 through phone at +92 51 910 73 17, 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 this 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. |