D-0532-2024 Class II Ongoing
FDA drug recall D-0532-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on May 10, 2024 and is designated Class II. Reason for recall: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit. The recall status is ongoing. Affected quantity: 3,480 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 12, 2024
- Initiation Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,480 cartons
Product Description
Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99
Reason for Recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Distribution Pattern
US Nationwide.
Code Information
Lot#: 19233788; Exp. 9/2025 Lot#: 19224445; Exp. 9/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0532-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026