The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets, it said.
Unichem said patients who unknowingly take Meloxicam have a reasonable probability of serious adverse events including cardiovascular, gastrointestinal, renal, anaphylaxis and skin reactions, particularly in the patients taking concomitant non-steroidal anti-inflammatory drugs and/or blood thinners, those who have allergies to the Meloxicam or those with underlying illness.
Meloxicam Tablets USP, 7.5 mg is a non-steroidal anti-inflammatory drug, indicated for use in osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis, Unichem said. Meloxicam Tablets, USP, 7.5 mg is light yellow, round flat bevelled edged, tablet with “U & L” debossed on one side and “7.5” debossed centrally on the other side.Meanwhile, the 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, Unichem said. The tablets are blue, film coated, round shaped, biconvex tablets, debossed with “U” on one side and “12” debossed on other side.
The mislabelled 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 bottle, Unichem said.
The product was distributed across the country to distributors, which then went to retailers and consumers. Unichem said its subsidiary is notifying its downstream partners, their retailers and consumers of the recall via its third party recall provider, Inmar.
Unichem Laboratories shares were trading 0.9% lower at ₹501.8 apiece around 12.40 pm. The stock has declined 32% this year, so far.
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