Drug product
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
D-0522-2026
Product summary
- Event
- Event 98803
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 165,761 90-count bottles
- Official record key
drug-enforcement:D-0522-2026
Official wording
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Code information: Lot: 241069C, Exp 05/31/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-duloxetine impurity
-
Manufacturing or process control
CGMP Deviations