Medicine recalls
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| The United States: Unichem Pharmaceuticals (USA) Inc. issues voluntary nationwide recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, due to mislabeling |
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The US Food and Drug Administration (FDA) announces that Unichem Pharmaceuticals (USA) Inc. is voluntarily recalling one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg (lot number: GMML24026A) to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets.
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. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Aug 28, 2025
Issued at HKT 17:45
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