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Amneal Pharmaceuticals of New York, LLC — Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
Failed Dissolution Specifications
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: Amneal Pharmaceuticals of New York, LLC
The product
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Details
- Units affected
- 9,263 100-count bottles
- Recall date
- October 27, 2023
- Brand
- Amneal Pharmaceuticals of New York, LLC
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: “Amneal Pharmaceuticals of New York, LLC — Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10”
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