PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: July 15, 2015 Initiated: May 19, 2015 #D-1232-2015

Product Description

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

Details

Recalling Firm
Hospira Inc.
Units Affected
106,900 vials
Distribution
U.S. Nationwide, Kuwait, Bahrain and Israel.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Hospira Inc.. Units affected: 106,900 vials.
Why was this product recalled?
Failed pH Specifications: 12 month stability testing
Which agency issued this recall?
This recall was issued by the FDA Drug on July 15, 2015. Severity: Low. Recall number: D-1232-2015.