Rizatriptan Benzoate Tablet
FDA Recall NDC 68462-466
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 68462-466). A significant event, classified as Class II, was initiated on May 10, 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 10, 2024
Jun 12, 2024
3,480 cartons
Recall Profile & Regulatory Data
Event ID
94606
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 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
Batch or Lot Expiration Information
Lot# : 19233788; Exp. 9/2025
Lot# : 19224445; Exp. 9/2024
Affected Packages Involved in this Recall
68462-465-72Product
68462-465-99Product
68462-466-72Product
68462-466-99Product
Class II Ongoing
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
May 10, 2024
Jun 12, 2024
11,976 cartons
Recall Profile & Regulatory Data
Event ID
94606
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 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
Batch or Lot Expiration Information
Lot# : 19224217; Exp. 9/2024
Lot# : 19233789; Exp. 9/2025
Lot# : 19224444; Exp. 9/2024
Affected Packages Involved in this Recall
68462-465-72Product
68462-465-99Product
68462-466-72Product
68462-466-99Product
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.
