Drug 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.
D-0655-2025
Product summary
- Event
- Event 97482
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 230 90-count bottles
- Official record key
drug-enforcement:D-0655-2025
Official wording
Reason: 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).
Code information: Lot No: GMML24026A, Expires: 09/30/2027
Distribution pattern: Nationwide within the U.S.A
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix Up