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
Reported: November 13, 2013 Initiated: August 17, 2013 #D-66014-001
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
Reason for Recall
Failed dissolution specifications; 18 month CRT
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC.
- Units Affected
- 895 - 1000 count bottles
- Distribution
- IL, NH, NJ, NY, OH, RI, TN
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC.. Units affected: 895 - 1000 count bottles.
Why was this product recalled? ▼
Failed dissolution specifications; 18 month CRT
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2013. Severity: Moderate. Recall number: D-66014-001.
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