Drug recall D-0655-2025
Product
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Reason for recall
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Lots and codes
Lot No: GMML24026A, Expires: 09/30/2027
Recall details
- Recalling firm
- Unichem Pharmaceuticals USA Inc., East Brunswick, NJ
- Quantity
- 230 90-count bottles
- Distribution
- Nationwide within the U.S.A
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 27, 2025
Related products
- Cyclobenzaprine Hydrochloride – drug information
- NDC 29300-413 Cyclobenzaprine hydrochloride · Cyclobenzaprine Hydrochloride 5 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-414 Cyclobenzaprine hydrochloride · Cyclobenzaprine Hydrochloride 7.5 mg/1 · Unichem Pharmaceuticals (USA), Inc.
- NDC 29300-415 Cyclobenzaprine hydrochloride · Cyclobenzaprine Hydrochloride 10 mg/1 · Unichem Pharmaceuticals (USA), Inc.