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Home Prescription medicine Amneal Pharmaceuticals of New York, LLC —…

Food & drug recall · FDAOctober 27, 2023Serious

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 seriousFDA 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
Model, lot or SKU numbers
Lot # HM03221A, Exp. date 12/31/2023
Where it was distributed

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

Read it on FDA

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

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