Unichem Laboratories subsidiary Unichem Pharmaceuticals (USA) Inc. is recalling one lot of muscle relaxant drug Cyclobenzaprine Hydrochloride Tablets USP 10 mg to the consumer level in the U.S. in the wake of mislabelling.
“The Cyclobenzaprine 10mg (90 count) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets,” the subsidiary cited as the reason for initiating the voluntary nationwide recall to the U.S. Food and Drug Administration.
A non-steroidal anti-inflammatory drug, Meloxicam Tablets USP, 7.5 mg is 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, the U.S. FDA said in a release.
The mislabelled bottles of Cyclobenzaprine Hydrochloride Tablets USP, 10mg but containing Meloxicam 7.5mg tablets, can be identified by the lot number and expiry date, it said, sharing details.
Serious adverse events likely
Those 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, the U.S. FDA said.
Unichem Pharmaceuticals has not received any reports of adverse events related to this recall, it said.
Published – August 28, 2025 04:11 pm IST
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