Drug Enforcement D-0655-2025

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).

Status

Ongoing

Classification

Class I

Report Date

September 24, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
230 90-count bottles
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).
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide within the U.S.A

Location & Firm

Recalling firm
Unichem Pharmaceuticals USA Inc.
Address
1 Tower Center Blvd Ste 2200, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0655-2025
Event ID
97482
Recall initiation date
August 27, 2025
Center classification date
September 17, 2025
Code info
Lot No: GMML24026A, Expires: 09/30/2027
More code info
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