Drug Enforcement D-0240-2025

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, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
Product quantity
133,824 bottles
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiation reason
—
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-0240-2025
Event ID
96194
Recall initiation date
January 29, 2025
Center classification date
February 20, 2025
Code info
Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.
More code info
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