Recall Alert
| DRAP Alert No | No I/S/11-24-47 |
| Action Date | 08th November, 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 | Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Hi-Z syrup (Reg. no. 075129) | 20mg Elemental Zinc/5ml | Batch No. S1427 Mfg Date: 07-2024 Exp Date: 06-20226 | M/s. Gulf Pharmaceuticals, Islamabad |
| Ufen Oral Suspension (Reg. No. 090274) | 100mg Ibuprofen/5ml | Batch No. S1451 Mfg Date: 08-2024 Exp Date: 07-20226 | M/s. Gulf Pharmaceuticals, Islamabad |
| Risk Statement: | Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batches of products 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. |