D-1429-2014 Class II Terminated
FDA drug recall D-1429-2014 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: 728,880 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
- 728,880 vials
Product Description
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
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 # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1429-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026