FDA recall D-1428-2014

Product

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-05-02

Report date

2014-07-16

Termination date

2016-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2014