August 2013 FDA Recall Extended Phenytoin Sodium by Amneal Pharmaceuticals Of New York, Llc.
D-66014-001 - Failed dissolution specifications; 18 month CRT

This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc. on August 17, 2013 for the product Extended Phenytoin Sodium. The FDA reported the reason for recall as failed dissolution specifications; 18 month crt. The product was distributed in IL, NH, NJ, NY, OH, RI, TN and the recall is currently terminated.

Recall Number: D-66014-001

Reason for Recall
Failed dissolution specifications; 18 month CRT
Initiated
08-17-2013
Reported
11-13-2013
Quantity
895 - 1000 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66014
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL, NH, NJ, NY, OH, RI, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-17-2014
Product Description About Product Description
Full technical description of the product.
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 or Lot Expiration Information

Lot# Batch/Lot HL50611, exp. 1/2014

Affected Packages Involved in this Recall

65162-212-03 Extended Phenytoin Sodium
65162-212-10 Extended Phenytoin Sodium
65162-212-50 Extended Phenytoin Sodium
65162-212-11 Extended Phenytoin Sodium