Unichem Pharmaceuticals (USA), Inc. has announced a voluntary recall of one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after discovering that bottles labeled as Cyclobenzaprine actually contained Meloxicam 7.5 mg tablets. The recall affects the consumer level nationwide.
According to the company, "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." Unichem Pharmaceuticals stated that no reports of adverse events related to this recall have been received so far.
Meloxicam is a non-steroidal anti-inflammatory drug used for conditions such as osteoarthritis and rheumatoid arthritis. The affected tablets are light yellow and marked with “U & L” on one side and “7.5” on the other. Cyclobenzaprine Hydrochloride Tablets USP 10 mg are muscle relaxers used alongside rest and physical therapy for muscle spasms; these tablets are blue, round, film-coated, debossed with “U” on one side and “12” on the other.
The mislabeled bottles can be identified by lot number GMML24026A with an expiry date of September 2027 and NDC 29300-415-19 printed on the label of the 90-count bottles.
Distribution was nationwide through distributors to retailers and consumers. Unichem Pharmaceuticals is notifying trading partners through its third-party provider Inmar about the recall process. Retail pharmacies are instructed not to dispense from this lot number and should notify customers if they have dispensed medication from it. Consumers should return affected medication to their pharmacy.
Consumers with questions can contact Inmar at 1-877-840-5109 or via email at orxrecalls@inmar.com during business hours Monday through Friday. Those experiencing problems related to this product should consult their healthcare provider.
Adverse reactions or quality issues can be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by mail/fax using forms available at www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration."
