FDA recall D-1232-2015

Product

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

Reason for recall

Failed pH Specifications: 12 month stability testing

Distribution

U.S. Nationwide, Kuwait, Bahrain and Israel.

Key facts

Status

Terminated

Initiation date

2015-05-19

Report date

2015-07-15

Termination date

2017-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1232-2015