Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot #: 39-569-DK, Exp 3/1/2016
Why it was recalled
Failed pH Specifications: 12 month stability testing
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 106,900 vials
- Distribution pattern
- U.S. Nationwide, Kuwait, Bahrain and Israel.
Timeline
- Recall initiated
- 2015-05-19
- FDA classified
- 2015-07-08
- Posted by FDA
- 2015-07-15
- Terminated
- 2017-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1232-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.