FDAFDA · Food and drugs·Recall number D-1428-2014
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02
Published July 16, 2014 · Recall initiated: May 2, 2014
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
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FOSPHENYTOIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0363323403010
- Lot
- Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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