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Teva Pharmaceuticals USA, Inc — Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: Teva Pharmaceuticals USA, Inc
The 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.
Details
- Units affected
- 116,144 bottles
- Recall date
- June 28, 2024
- Brand
- Teva Pharmaceuticals USA, Inc
Nationwide in the USA and Puerto Rico
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Teva Pharmaceuticals USA, Inc — 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”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine