D-1232-2015 Class III Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA drug recall D-1232-2015 was initiated by Hospira Inc. on May 19, 2015 and is designated Class III. Reason for recall: Failed pH Specifications: 12 month stability testing The recall status is terminated (terminated Dec 4, 2017). Affected quantity: 106,900 vials.

Recall Details

Product Type
Drugs
Report Date
Jul 15, 2015
Initiation Date
May 19, 2015
Termination Date
Dec 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
106,900 vials

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

Distribution Pattern

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

Code Information

Lot #: 39-569-DK, Exp 3/1/2016

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1232-2015
openFDA file date
Oct 27, 2026
Loaded by RegDataLab
Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.