FDAFDA · Food and drugs·Recall number D-66014-001
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
Published November 13, 2013 · Recall initiated: August 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed dissolution specifications; 18 month CRT
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC.
- Distributor
- IL, NH, NJ, NY, OH, RI, TN
- UPC
- 0365162212037
- Lot
- Batch/Lot HL50611, exp. 1/2014
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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