FDA-Drug2014-07-16Class II
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
Fresenius Kabi USA, LLC
Hazard
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Sold states
Nationwide and Puerto Rico
Affected count
728,880 vials
Manufactured in
2045 Cornell Ave, Melrose Park, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2014Don't want to check this manually?
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