D-1232-2015 Class III Terminated
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