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FDARecalled Jul 23, 2025 · #D-0534-2025

Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. Classification: Class II Distribution: US Nationwide.

Product details

Product
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18
Type
Drugs
Manufacturer
Ascend Laboratories, LLC
Model numbers
22143653, 22144528, 22144977, 23140257, 23140999, 23141900, 23144563, 24142623, 24142624
UPCs