Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
Reported: June 12, 2024 Initiated: May 10, 2024 #D-0533-2024
Product Description
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99
Reason for Recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 11,976 cartons
- Distribution
- US Nationwide.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 11,976 cartons.
Why was this product recalled? ▼
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 12, 2024. Severity: Moderate. Recall number: D-0533-2024.
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