Class III
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- February 5, 2018
- Posted
- February 21, 2018
- Recall Number
- D-0578-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,157,095 bottles
- Firm Location
- North Wales, PA, United States
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
Distributed throughout the United States
Lot / Code Info
All lots within expiry.
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