D-0578-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2018
- Initiation Date
- February 5, 2018
- Termination Date
- April 30, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,157,095 bottles
Product Description
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
Reason for Recall
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.
Distribution Pattern
Distributed throughout the United States
Code Information
All lots within expiry.