Recall Alert
| DRAP Alert No | No I/S/08-23-22 |
| Action Date | 06th 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 | The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis. |
Therapeutic Goods Affected:-
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Plivil 25mg/ml Injection Reg No 021513 | Pheniramine Maleate 25mg/ml | Batch No 847 Mfg date 02.2023 Exp date 02.2025 | M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan. |
| Risk Statement: | Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose. |
| 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. |