Drug product
Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
D-0181-2016
Product summary
- Event
- Event 72563
- Status
- Terminated
- Classification
- Class III
- Quantity
- 595 Bottles
- Official record key
drug-enforcement:D-0181-2016
Official wording
Reason: Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Code information: Lot #: 142391, Exp 10/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets