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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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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
Distribution Pattern IL, NH, NJ, NY, OH, RI, TN

Product Detail

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