Rizatriptan Benzoate Tablets USP recall: Impurity Out of Spec
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of…
Why was Rizatriptan Benzoate Tablets USP recalled?
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
- Product
- Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 3,480 cartons
- Distribution
- US Nationwide.
- Recall date
- June 12, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)