FDA recall D-0243-2025

Glenmark Pharmaceuticals Inc., USA · Class II · drug

Product

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

Reason for recall

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

Distribution

Nationwide within the U.S

Key facts

Status: Ongoing
Initiation date: 2025-01-29
Report date: 2025-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2025