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.
Reported: July 24, 2024 Initiated: June 28, 2024 #D-0601-2024
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA, Inc
- Units Affected
- 116,144 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA, Inc. Units affected: 116,144 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2024. Severity: Moderate. Recall number: D-0601-2024.
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