Recalls / Class II
Class IID-1428-2014
Product
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
- Brand name
- Fosphenytoin
- Generic name
- Fosphenytoin Sodium
- Active ingredient
- Fosphenytoin Sodium
- Route
- Intramuscular, Intravenous
- NDC
- 63323-403
- FDA application
- ANDA078052
- Affected lot / code info
- 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
Why it was recalled
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2045 Cornell Ave, Melrose Park, Illinois 60160-1002
Distribution
- Quantity
- 2,070,500 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-05-02
- FDA classified
- 2014-07-09
- Posted by FDA
- 2014-07-16
- Terminated
- 2016-05-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1428-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.