Rapid Alert
| Spurious/Falsified Drug product (Brexin Tablet) |
| DRAP Alert No | No I/S/10-26-44 |
| Action Date | 22nd October, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control departments. Healthcare Professionals Consumers |
| Problem Statement | Drug Testing Laboratory (DTL) Sindh, Karachi declared the following sample as Spurious/Falsified under Section 3(z-b) (ii) & 3(z-b) (i) of the Drugs Act, 1976. The sample was referred to DTL Sindh, Karachi, by the Area Provincial Inspector of Drugs, Karachi. The manufacturer has disowned the sample. |
| Sr. No. | Name of Product | Batch number | Name of Manufacturer | Remarks |
| 1 | Brexin Tablet | W68C | Purported to be manufactured by: M/s Glaxo Smith Kline Pakistan Ltd, F/268 SITE Karachi Under license of M/s Chiesi Farmaceutici S.p.A Pharma Italy. | The sample is declared as “Spurious” since it does not contain the active ingredient i.e. Piroxicam B-Cyclodextrin. |
| Risk Statement | Use of the above-mentioned products may result in treatment failure due to the absence of the declared active ingredient and may pose potential risks to patient safety. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments have been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link. |
| Advice for Consumers | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |