Drug Enforcement D-0533-2024

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Status

Ongoing

Classification

Class II

Report Date

June 12, 2024

Termination Date

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Product Information

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
Product quantity
11,976 cartons
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide.

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0533-2024
Event ID
94606
Recall initiation date
May 10, 2024
Center classification date
June 4, 2024
Code info
Lot#: 19224217; Exp. 9/2024 Lot#: 19233789; Exp. 9/2025 Lot#: 19224444; Exp. 9/2024
More code info
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