Meloxicam

Unichem Pharmaceuticals voluntarily recalled one lot of the muscle relaxant cyclobenzaprine hydrochloride due to a labeling mix-up. The U.S. subsidiary of India’s Unichem Pharmaceuticals is voluntarily recalling one lot of the muscle relaxant cyclobenzaprine hydrochloride after a labeling snafu.The lot being recalled is identified as #GMML24026A. While the labels indicate the bottles contain 10-mg tablets of cyclobenzaprine, at least one label was placed on a bottle filled with 7.5-mg tablets of meloxicam, according to the company's Aug. 27 recall announcement.Meloxicam is used to treat osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis.Meloxicam tablets are light yellow and flat with a beveled edge, while cyclobenzaprine tablets are blue, round, film-coated and have a debased “U” on one side and the number “12” on the other, the company noted.The products were distributed nationwide in the U.S.Patients who mistakenly take meloxicam could experience cardiovascular, gastrointestinal, renal and other side effects, particularly for those who are on nonsteroidal anti-inflammatory drugs and/or blood thinners.So far, Unichem says it has received no reports of adverse effects related to the recall. Unichem said it's using a third-party provider, Inmar, to notify and accept returns of the recalled drug.

Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) Product Description: Product Description Cyclobenzaprine Hydrochloride Tablets USP 10 mg Company Announcement FOR IMMEDIATE RELEASE – 08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. Risk Statement: For patients who unknowingly take Meloxicam there is a reasonable probability of serious adverse events including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients taking concomitant non-steroidal anti-Inflammatory drugs and/or blood thinners, those who have allergies to the Meloxicam, or those with underlying illness. To date, Unichem Pharmaceuticals has not received any reports of adverse events related to this recall. Meloxicam Tablets USP, 7.5 mg is a non-steroidal anti-inflammatory drug, indicated for use in Osteoarthritis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis. Meloxicam Tablets, USP, 7.5 mg is light yellow, round flat beveled edged, tablet with “U & L” debossed on one side and “7.5” debossed centrally on the other side. Cyclobenzaprine Hydrochloride Tablets USP, 10mg is a muscle relaxer and indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, are blue colored, film coated, round shaped, biconvex tablets, debossed with “U” on one side and “12” debossed on other side. The mislabeled bottles of Cyclobenzaprine Hydrochloride Tablets USP, 10mg but containing Meloxicam 7.5mg tablets, can be identified by the lot number GMML24026A and expiry of Sept 2027 and NDC 29300-415-19 printed on the label of the 90-count bottles. The product was distributed Nationwide to distributors, and further downstream distribution occurred to retailers and subsequently consumers. Unichem Pharmaceuticals (USA), Inc. is notifying its downstream trading partners, their retailers and consumers of the recall through our third party recall provider, Inmar. Inmar is arranging for the return of the subject recalled Cyclobenzaprine Hydrochloride Tablets USP, 10mg labeled with Lot # GMML24026A. Our downstream trading partners that have Cyclobenzaprine Hydrochloride Tablets USP, 10mg with Lot# GMML24026A, Exp Sept 2027, which is being recalled, should not further distribute, this medication, and notify their customers accordingly. Retail pharmacies should not dispense from this lot number, GMML24026A, and call the number provided for guidance on how to return this drug product. Any pharmacy who has dispensed this lot of Cyclobenzaprine, should notify the consumer. Consumers should return the medication to the pharmacy they received their prescription from. Consumers with questions regarding this recall can Inmar at 1-877-840-5109 or via email a to rxrecalls@inmar.com ; Monday – Friday (9 am – 5 pm; CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. The Product Label Subject to this recall is shown below: Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.