Rizatriptan Benzoate Tablet, Orally Disintegrating
FDA Recall NDC 68462-468
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Rizatriptan Benzoate (NDC 68462-468). A significant event, classified as Class II, was initiated on May 13, 2024 by Glenmark Pharmaceuticals Inc., Usa. The reported reason for this action was: "CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
May 13, 2024
Jun 12, 2024
2400 cartons
Recall Profile & Regulatory Data
Event ID
94608
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
Batch or Lot Expiration Information
Lot# : 19224857; Exp. 11/2024
Lot# : 19232493; Exp. 6/2025
Affected Packages Involved in this Recall
68462-467-74Product
68462-467-46Product
68462-467-06Product
68462-468-74Product
68462-468-46Product
68462-468-06Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
May 13, 2024
Jun 12, 2024
13296 cartons
Recall Profile & Regulatory Data
Event ID
94608
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06
Batch or Lot Expiration Information
Lot# : 19223402; Exp. 7/2024
Lot# : 19224858; Exp. 11/2024
Lot# : 19232492; Exp. 6/2025
Affected Packages Involved in this Recall
68462-467-74Product
68462-467-46Product
68462-467-06Product
68462-468-74Product
68462-468-46Product
68462-468-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
