Reported Nov 13, 2013 · Terminated

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11…

Amneal Pharmaceuticals of New York, LLC.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals of New York, LLC. · 85 Adams Avenue · Hauppauge, NY · 11788

Is this the product you have?

  • Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label
  • NDC 65162-212-11 --- Manufactured byAmneal Pharmaceuticals of NY Hauppauge
  • NY 11788 Distributed byAmneal Pharmaceuticals Glasgow, KY 42141
Lot codes and dates
    • Batch/Lot HL50611
    • exp. 1/2014
Amount recalled
895 - 1000 count bottles

Where it was sold

Why it was recalled

Failed dissolution specifications; 18 month CRT

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 17, 2014 · Data as of Sep 19, 5:05 PM UTC

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