Class II
Ongoing
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.
This recall is currently active, issued July 24, 2024. It was issued by Teva Pharmaceuticals Usa, Inc.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- June 28, 2024
- Posted
- July 24, 2024
- Recall Number
- D-0601-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 116,144 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
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
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.
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