Teva Pharmaceuticals USA, Inc: 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:

Hazard

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

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits. Distribution: Nationwide in the USA and Puerto Rico Quantity: 116,144 bottles Lot/code info: Lot #s: CNSDH, Exp. 6/30/2024; CNWVM, CNWWH, Exp. 07/31/2024; CNXKW, CNXKY, CNXMB, CNXMH, Exp. 09/30/2024; CPBTP, CPBTV, Exp. 11/30/2024.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.