Class II
Terminated
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
This recall has been terminated (originally issued November 13, 2013).
- Recall Initiated
- August 17, 2013
- Posted
- November 13, 2013
- Recall Number
- D-66014-001
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 895 - 1000 count bottles
- Firm Location
- Hauppauge, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed dissolution specifications; 18 month CRT
Distribution
IL, NH, NJ, NY, OH, RI, TN
Lot / Code Info
Batch/Lot HL50611, exp. 1/2014
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