Recalling firm
Breckenridge Pharmaceutical, Inc
Product type
Drug
Status
Ongoing
Report date
2025-01-01
Distribution
Nationwide in the US
Firm state
CT
Product quantity
163,883 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product description
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.
Code / lot info
Lot # 222205C, exp. date 11/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.