Drug recall D-0308-2025
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
Reason for recall
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Lots and codes
Lot 240909C, Exp Date 03/31/2027
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
- Quantity
- 14,863 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 26, 2025
Related products
- Duloxetine – drug information
- NDC 51991-747 Duloxetine Delayed-Release · Duloxetine Hydrochloride 30 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-750 Duloxetine Delayed-Release · Duloxetine Hydrochloride 40 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-748 Duloxetine Delayed-Release · Duloxetine Hydrochloride 60 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-746 Duloxetine Delayed-Release · Duloxetine Hydrochloride 20 mg/1 · Breckenridge Pharmaceutical, Inc.