Recall Alert
| DRAP Alert No | No I/S/11-24-46 |
| Action Date | 28th October 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 | M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of voluntary recall of the following product through public notice. The details of the product are as below: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Neo-pyrolate Injection IV 1ml × 10’s | Glycopyrrolate + Neostigmine Methylsulphate | Batch No. 105B24 Mfg. date: 02-2024 Exp. date: 02-2026 | M/s Brookes Pharma (Pvt.) Ltd, Karachi. |
| Risk Statement: | The use of substandard injection may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions. |
| Action Initiated | The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to conduct market surveillance for the detection of the presence and removal of the recalled batches from the market. |
| Advice for Healthcare Professionals | All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned product. The remaining stocks 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). -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 products bearing the affected batch number(s) and should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to the Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre.. -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. |