D-1428-2014 Class II Terminated
FDA drug recall D-1428-2014 was initiated by Fresenius Kabi USA, LLC on May 2, 2014 and is designated Class II. Reason for recall: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. The recall status is terminated (terminated May 24, 2016). Affected quantity: 2,070,500 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 16, 2014
- Initiation Date
- May 2, 2014
- Termination Date
- May 24, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,070,500 vials
Product Description
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
Reason for Recall
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1428-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026