Fresenius Kabi USA, LLC: 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,

Is my product affected?

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 FOSPHENYTOIN

Check against the official notice below — it lists the full affected range.

What happened

Fresenius Kabi USA is recalling approximately 728,880 vials of Fosphenytoin Sodium Injection, a prescription medication used to treat seizures. The recall affects vials distributed nationwide and in Puerto Rico across multiple lot numbers manufactured between April 2014 and November 2015. The vials are being recalled because of potential glass delamination, with glass particulates observed in sample vials tested during the recall investigation.

According to the recall record, no remedy has been specified for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Details from the source

Reason for recall: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. Distribution: Nationwide and Puerto Rico Quantity: 728,880 vials 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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