FDA enforcement lists 230 bottles of Cyclobenzaprine labeled incorrectly as Meloxicam. The labeling error was detected in a nationwide recall. Health professionals and patients should stop using the mislabeled bottles immediately. Contact Unichem Pharmaceuticals USA or a clinician for guidance.
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).
Consumers and healthcare providers should stop using this product immediately. Contact Unichem Pharmaceuticals USA Inc. or your healthcare provider for guidance. Notification method: Press Release
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Cyclobenzaprine is a muscle relaxant prescribed for short-term relief of muscle spasms. Labels must correctly identify the active ingredient.
The label mix-up could lead to incorrect medication administration, potential adverse drug reactions, and reduced therapeutic efficacy.
This recall is not described as part of a broader industry pattern.
The immediate impact is confusion and potential harm if the wrong drug is taken. No injuries reported yet.
FDA recall page and Unichem Pharmaceuticals USA, Inc. communications
Refund or replacement timelines will be provided by recall notices; typically several weeks
Keep bottle, packaging, and recall notices; note lot and expiration date
Product: Cyclobenzaprine Hydrochloride Tablets USP, 10 mg, 90-count bottle. Manufacturer: Unichem Laboratories Ltd, India. Manufactured for: Unichem Pharmaceuticals USA, Inc., East Brunswick, NJ. NDC 29300-415-19. Quantity: 230 bottles. Lot: GMML24026A. Expiration: 09/30/2027. Distribution: Nationwide in the USA.
No injuries or incidents have been reported in the recall notice.
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