Recalls / Class II

Class IID-0601-2024

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.

Affected 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.

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.

Recalling firm

Firm

Teva Pharmaceuticals USA, Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120

Distribution

Quantity

116,144 bottles

Distribution pattern

Nationwide in the USA and Puerto Rico

Timeline

Recall initiated

2024-06-28

FDA classified

2024-07-16

Posted by FDA

2024-07-24

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0601-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.