D-0578-2018 Class III Terminated
FDA drug recall D-0578-2018 was initiated by Teva Pharmaceuticals USA on Feb 5, 2018 and is designated Class III. 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… The recall status is terminated (terminated Apr 30, 2019). Affected quantity: 1,157,095 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 21, 2018
- Initiation Date
- Feb 5, 2018
- Termination Date
- Apr 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0578-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026