Fludrocortisone Acetate Tablets recalled nationwide due to failed impurity and degradation specifications
Teva Pharmaceuticals is recalling Fludrocortisone Acetate Tablets 0.1mg nationwide and in Puerto Rico due to impurities and degradation substances exceeding specification limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving unknown impurities and degradation substances exceeding specification limits in a prescription corticosteroid. No illnesses or injuries have been reported. Per the severity rubric, this represents a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Fludrocortisone Acetate Tablets, USP 0.1mg in bottles of 100 tablets due to API-related substances and unknown impurities that exceed specification limits. The affected product was manufactured in Canada by Patheon, Inc. and distributed nationwide in the USA and Puerto Rico.
Approximately 116,144 bottles are affected. The affected lot numbers include CNSDH (expiring 6/30/2024), CNWVM and CNWWH (expiring 7/31/2024), CNXKW, CNXKY, CNXMB, and CNXMH (expiring 9/30/2024), and CPBTP and CPBTV (expiring 11/30/2024).
Consumers and healthcare providers who have Fludrocortisone Acetate Tablets with these lot numbers should contact their pharmacist or healthcare provider. Do not use the product and return it to your pharmacy for replacement or refund.
The recalled product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Affected units
- 116,144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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.
Distribution
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