Drug Enforcement D-0534-2024

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

—

Product Information

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
Product quantity
2400 cartons
Reason for recall
CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiation reason
—
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-0534-2024
Event ID
94608
Recall initiation date
May 13, 2024
Center classification date
June 4, 2024
Code info
Lot#: 19224857; Exp. 11/2024 Lot#: 19232493; Exp. 6/2025
More code info
—