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.