USFDA12 April 2026 at 01:30 pm
Unichem Labs US subsidiary recalls Buspirone Hydrochloride tablets
AI Summary
Unichem Pharmaceuticals (USA), Inc., a wholly-owned subsidiary of Unichem Laboratories Ltd, has voluntarily recalled its Buspirone Hydrochloride Tablets, USP, 5 mg, 500 count bottles, distributed in the USA. The recall was initiated due to an out-of-specification (OOS) assay result identified at the 12-month long-term stability time point. The company has not received any reports of adverse events related to this recall to date and emphasizes its highest priority on ensuring patient safety and maintaining product quality throughout its manufacturing and supply chain processes.
Key Highlights
- Unichem's US subsidiary voluntarily recalled Buspirone Hydrochloride tablets.
- Recall due to out-of-specification assay result at 12-month stability.
- No adverse events reported related to the product recall to date.
- Company prioritizes patient safety and product quality standards.