Fludrocortisone Acetate Tablets recall

Why it was recalled

Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.

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.

Recalling company

Teva Pharmaceuticals USA, Inc.

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA and Puerto Rico

Initiated

Jun 28, 2024

FDA report date

Jul 24, 2024