Cyclobenzaprine bottles recalled after being filled with meloxicam tablets instead
Unichem Cyclobenzaprine Hydrochloride Tablets, 10 mg, lot GMML24026A, are recalled because bottles labeled as cyclobenzaprine contained yellow Meloxicam 7.5 mg tablets. The FDA classified the action as Class I.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this label mix-up as Class I.
Plain-English summary
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, in 90-count bottles and available on prescription only, manufactured by Unichem Laboratories, Ltd in Goa, India for Unichem Pharmaceuticals (USA), Inc. of East Brunswick, New Jersey, are being recalled. The affected product is lot GMML24026A, expiring 09/30/2027, and the recall covers 230 90-count bottles distributed nationwide.
The recall was issued because of a label mix-up: bottles of Meloxicam USP 7.5 mg 90-count tablets, which are yellow, were labeled as Cyclobenzaprine Hydrochloride Tablets USP 10 mg 90-count tablets, which are blue. The FDA classified the action as Class I, its most serious category.
Patients should check the lot number on their bottle and the appearance of the tablets, and should contact their pharmacist before taking any tablet that does not match the expected description.
The recalled product
- Product
- CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRINE HYDROCHLORIDE)
- Brand
- CYCLOBENZAPRINE HYDROCHLORIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Category
- Drug — Musculoskeletal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No: GMML24026A
- Expires: 09/30/2027
Distribution
Distributed nationwide across the United States.
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