FDA-Drug2025-04-30Class II
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Breckenridge Pharmaceutical, Inc
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Sold states
US Nationwide.
Affected count
16,473 bottles
Manufactured in
15 Massirio Dr Ste 201, N/A, Berlin, CT, United States
Products
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0387-2025Don't want to check this manually?
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