Clarification3 Sept 2025, 11:47 am
Unichem Pharmaceuticals (USA) Recalls Cyclobenzaprine Hydrochloride Tablets USP 10 mg Due to Mislabeling
AI Summary
Unichem Pharmaceuticals (USA), Inc., a wholly-owned subsidiary of Unichem Laboratories Ltd, has voluntarily recalled one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg due to mislabeling. The mislabeled bottles contain Meloxicam 7.5 mg tablets instead. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The risk of serious adverse events for patients who unknowingly take Meloxicam includes cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions. To date, Unichem Pharmaceuticals has not received any reports of adverse events related to this recall.
Key Highlights
- Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg due to mislabeling.
- The mislabeled bottles contain Meloxicam 7.5 mg tablets instead of Cyclobenzaprine Hydrochloride Tablets USP 10 mg.
- The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
- Risk of serious adverse events for patients who unknowingly take Meloxicam.
- No reports of adverse events related to this recall have been received by Unichem Pharmaceuticals.