FDA-Drug2018-02-21Class III
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
Teva Pharmaceuticals USA
Hazard
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.
Sold states
Distributed throughout the United States
Affected count
1,157,095 bottles
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2018Don't want to check this manually?
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