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
Reported: February 21, 2018 Initiated: February 5, 2018 #D-0578-2018
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 1,157,095 bottles
- Distribution
- Distributed throughout the United States
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 1,157,095 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 21, 2018. Severity: Low. Recall number: D-0578-2018.
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