FDA-Drug2025-11-05Class IICHEMICAL
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Hazard
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
172,263 bottles
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2026Want us to check the next one for you?
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