Fludrocortisone Acetate Tablets recall: Impurity Out of Spec
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N…
Why was Fludrocortisone Acetate Tablets recalled?
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N…
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Quantity
- 116,144 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)