Drug FDA Class II Ongoing cGMP deviation
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
Glenmark Pharmaceuticals Inc., USA Published Jun 12, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Hazards
N-Nitroso Desmethyl Rizatriptan · primary
Affected products (1)
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
RIZATRIPTAN BENZOATE · 13296 cartons
NDC: 68462-467, 68462-468, 68462-467-74, 68462-467-46, 68462-467-06, 68462-468-74, 68462-468-46, 68462-468-06
Code info: Lot#: 19223402; Exp. 7/2024 Lot#: 19224858; Exp. 11/2024 Lot#: 19232492; Exp. 6/2025
Affected areas
Nationwide
Timeline
- InitiatedMay 13, 2024
- PublishedJun 12, 2024
- Recall number
- D-0535-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.