Teva Pharmaceuticals USA, Inc recalls Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., M
Recalled July 24, 2024 · FDA recall D-0601-2024 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. · FDA Class II
Units
116,144 bottles
Sold at
Nationwide in the USA and Puerto Rico
Description
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Product
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.
Manufacturer(s)
Teva Pharmaceuticals USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →