D-0601-2024 Class II Ongoing
FDA drug recall D-0601-2024 was initiated by Teva Pharmaceuticals USA, Inc on Jun 28, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 116,144 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 24, 2024
- Initiation Date
- Jun 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116,144 bottles
Product Description
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.
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 Pattern
Nationwide in the USA and Puerto Rico
Code Information
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
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0601-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026