Why it was recalled
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Product description
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
Lot numbers, UPCs & expiration codes
Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0534-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 13, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- 2400 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0534-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94608
- Address
- 750 Corporate Dr
- Code information
- Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
- Postal code
- 07430-2009
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0534-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 2400 cartons
- Reason for recall
- CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 13, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2024