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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Extended 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
Recall Number D-66014-001
Classification Class II
Code Info Batch/Lot HL50611, exp. 1/2014
Product Distributed Qty 895 - 1000 count bottles
Reason For Recall Failed dissolution specifications; 18 month CRT

Event Detail

Event Id 66014
Product Type Drugs
Status Ongoing
Recalling Firm Amneal Pharmaceuticals of New York, LLC.
City Hauppauge
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern IL, NH, NJ, NY, OH, RI, TN