Fresenius Kabi USA, LLC: 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

Is my product affected?

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 FOSPHENYTOIN

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

What happened

Fresenius Kabi USA, LLC is recalling Fosphenytoin Sodium Injection, USP, a prescription injectable medication, due to the presence of particulate matter resulting from potential glass delamination in the vials. The recall affects 2,070,500 vials distributed nationwide and in Puerto Rico across multiple lot numbers manufactured between April 2014 and July 2015.

The recall was initiated because glass particulates consistent with glass delamination were observed in sample vials, creating a potential hazard for patients receiving this medication. The source document does not specify what actions affected consumers or healthcare providers should take in response to this recall.

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: 2,070,500 vials 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

Source

Official record: FDA (Drug enforcement) ↗

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

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