An urgent recall has been issued for medication that’s been mislabeled, leading the FDA to warn that some Americans could suffer life-threatening reactions if they consume the incorrect pills.
New Jersey-based Unichem Pharmaceuticals is voluntarily recalling one lot of Cyclobenzaprine Hydrochloride Tablets USP in 10 mg pills.
A label of Cyclobenzaprine 10mg (90ct) was incorrectly placed on a bottle containing Meloxicam 7.5 mg tablets.
Cyclobenzaprine, common brands Fexmid and Amrix, is a prescription-only muscle relaxant to treat muscle spasms. It is typically only used for two to three weeks at a time.
Meloxicam, common brands Mobic and Vivlodex, is a prescription nonsteroidal anti-inflammatory drug (NSAID) used to treat pain, inflammation, and stiffness associated with various types of arthritis.
The FDA said in its recall notice: ‘For patients who unknowingly take Meloxicam there is a reasonable probability of serious adverse events including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions.’
Reactions can occur particularly in people who regularly take other NSAIDs for certain medical conditions, or in people who are allergic to Meloxicam and have certain comorbidities.
Pictured above are Meloxicam tablets. In the recent recall, a label for Cyclobenzaprine was mistakenly placed on a bottle containing Meloxicam pills
Pictured above are Cyclobenzaprine Hydrochloride tablets. In the recent recall, a label for Cyclobenzaprine was mistakenly placed on a bottle containing Meloxicam pills
There have been no adverse events reported to date related to this recall.
Meloxicam is used in people with osteoarthritis, rheumatoid arthritis and juvenile rheumatoid arthritis. These conditions are suffered by approximately 34.3 million Americans combined.
According to some estimates, there are about 20.7million prescriptions written for the drug for nearly 7million patients in the US per year.
Meloxicam tablets are round, light yellow and have ‘U & L’ engraved on one side and ‘7.5’ engraved on the other side.
Meanwhile, Cyclobenzaprine Hydrochloride tablets USP are round, blue, film coated and engraved with ‘U’ on one side and ’12’ on other side.
About 24million prescriptions were written for the drug in 2024. They are used as short-term pain and soreness treatment for discomfort caused by muscle spasms.
The mislabeled bottles of Cyclobenzaprine Hydrochloride can be identified by their lot number: GMML24026A.
They have an expiration date of September 2027 and NDC 29300-415-19 is printed on the label of the 90-count bottles.
The above shows a label for Cyclobenzaprine Hydrochloride tablets
The above shows a label for Cyclobenzaprine Hydrochloride tablets
The pills were distributed nationwide to distributors and furthermore to retailers and consumers.
The company is advising any location with the mislabeled bottles to stop distributing the medication and notify customers of the mistake.
Additionally, retail pharmacies should not dispense the medication and contact Inmar, the company arranging for the return of the recalled product, for further instructions.
The pharmacies should also contact and notify customers, who should then return the mislabeled medication to the place of purchase.
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