Drug 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
D-1232-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71382
- Status
- Terminated
- Classification
- Class III
- Quantity
- 106,900 vials
- Official record key
drug-enforcement:D-1232-2015
Official wording
Reason: Failed pH Specifications: 12 month stability testing
Code information: Lot #: 39-569-DK, Exp 3/1/2016
Distribution pattern: U.S. Nationwide, Kuwait, Bahrain and Israel.
Derived failure modes
-
Unknown
Failed pH Specifications: 12 month stability testing