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 HL50611exp. 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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