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
Reported: July 16, 2014 Initiated: May 2, 2014 #D-1429-2014
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 728,880 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 728,880 vials.
Why was this product recalled? ▼
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 16, 2014. Severity: Moderate. Recall number: D-1429-2014.
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