FDA-Drug2025-09-24Class I
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.
Unichem Pharmaceuticals USA Inc.
Hazard
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).
Sold states
Nationwide within the U.S.A
Affected count
230 90-count bottles
Manufactured in
1 Tower Center Blvd Ste 2200, N/A, East Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2025Don't want to check this manually?
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