Recalls / Class II
Class IID-1429-2014
Product
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
- 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 # 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
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
- 728,880 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-1429-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.