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Unichem recalling muscle relaxant in U.S. due to mislabelling


Unichem Laboratories subsidiary Unichem Prescribed drugs (USA) Inc. is recalling one lot of muscle relaxant drug Cyclobenzaprine Hydrochloride Tablets USP 10 mg to the patron stage within the U.S. within the wake of mislabelling.

“The Cyclobenzaprine 10mg (90 depend) label was inadvertently positioned on a bottle containing Meloxicam 7.5 mg tablets,” the subsidiary cited as the explanation for initiating the voluntary nationwide recall to the U.S. Meals and Drug Administration.

A non-steroidal anti-inflammatory drug, Meloxicam Tablets USP, 7.5 mg is indicated to be used in osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis. Cyclobenzaprine Hydrochloride Tablets USP, 10mg is a muscle relaxer and indicated as an adjunct to relaxation and bodily remedy for reduction of muscle spasm related to acute, painful musculoskeletal situations, the U.S. FDA stated in a launch.

The mislabelled bottles of Cyclobenzaprine Hydrochloride Tablets USP, 10mg however containing Meloxicam 7.5mg tablets, will be recognized by the lot quantity and expiry date, it stated, sharing particulars.

Severe hostile occasions doubtless

Those that unknowingly take Meloxicam there’s a affordable likelihood of significant hostile occasions, together with cardiovascular, gastrointestinal, renal, anaphylaxis and pores and skin reactions, significantly in these sufferers taking concomitant non-steroidal anti-Inflammatory medicine and/or blood thinners, those that have allergic reactions to the Meloxicam, or these with underlying sickness, the U.S. FDA stated.

Unichem Prescribed drugs has not obtained any stories of hostile occasions associated to this recall, it stated.