Drug product
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
D-0578-2018
Product summary
- Event
- Event 79118
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,157,095 bottles
- Official record key
drug-enforcement:D-0578-2018
Official wording
Reason: Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Code information: All lots within expiry.
Distribution pattern: Distributed throughout the United States
Derived failure modes
-
Potency or specification failure
out of specification