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FDARecalled Jul 24, 2024 · #D-0601-2024

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, I...

Hazard

Class II — temporary health risk

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Description

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico

Product details

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.
Type
Drugs
Manufacturer
Teva Pharmaceuticals USA, Inc
Model numbers
UPCs