FDA-Drug2025-07-23Class II
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Ascend Laboratories, LLC
Hazard
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
135 Us Highway 202 206 Ste 15, N/A, Bedminster, NJ, United States
Products
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0533-2025Don't want to check this manually?
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