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
Reported: July 23, 2025 Initiated: July 9, 2025 #D-0534-2025
Product Description
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
Reason for Recall
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Details
- Recalling Firm
- Ascend Laboratories, LLC
- Units Affected
- N/A
- Distribution
- US Nationwide.
- Location
- Bedminster, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ascend Laboratories, LLC. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0534-2025.
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