Drug Enforcement D-66014-001

Failed dissolution specifications; 18 month CRT

Status

Terminated

Classification

Class II

Report Date

November 13, 2013

Termination Date

July 17, 2014

Product Information

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
Product quantity
895 - 1000 count bottles
Reason for recall
Failed dissolution specifications; 18 month CRT
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
IL, NH, NJ, NY, OH, RI, TN

Location & Firm

Recalling firm
Amneal Pharmaceuticals of New York, LLC.
Address
85 Adams Avenue, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-66014-001
Event ID
66014
Recall initiation date
August 17, 2013
Center classification date
November 4, 2013
Code info
Batch/Lot HL50611, exp. 1/2014
More code info
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