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Class II · ModerateRecall completed

Extended Phenytoin Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch/Lot HL50611, exp. 1/2014
Where it was soldIL, NH, NJ, NY, OH, RI, TN
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed dissolution specifications; 18 month CRT

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Brand nameEXTENDED PHENYTOIN SODIUM
Generic namePHENYTOIN SODIUM
Active ingredient(s)PHENYTOIN SODIUM
Distributed by / forAmneal Pharmaceuticals Glasgow, KY 42141
NDC65162-212-11
Show the full FDA record
Full product labelExtended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141
Recalling firmAmneal Pharmaceuticals of New York, LLC.
DistributionIL, NH, NJ, NY, OH, RI, TN
Quantity895 - 1000 count bottles
Recall initiated2013-08-17
Report date2013-11-13
Recall completed2014-07-17
Recall numberD-66014-001
ClassificationClass II
FDA statusTerminated
Origin on fileHauppauge NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.