FDA-Drug2025-01-01Class II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Breckenridge Pharmaceutical, Inc
Hazard
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Sold states
Nationwide in the US
Affected count
163,883 bottles
Manufactured in
15 Massirio Dr Ste 201, Berlin, CT, United States
Products
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0161-2025Don't want to check this manually?
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