FDA-Drug2024-07-24Class II
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Teva Pharmaceuticals USA, Inc
Hazard
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
116,144 bottles
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0601-2024Don't want to check this manually?
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