Drug Enforcement D-0231-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Status

Ongoing

Classification

Class II

Report Date

February 26, 2025

Termination Date

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Product Information

Product description
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Product quantity
70,032 bottles
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S

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-0231-2025
Event ID
96194
Recall initiation date
January 29, 2025
Center classification date
February 20, 2025
Code info
Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
More code info
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