Why it was recalled
Failed pH Specifications: 12 month stability testing
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
Lot numbers, UPCs & expiration codes
Lot #: 39-569-DK, Exp 3/1/2016
Where it was sold
U.S. Nationwide, Kuwait, Bahrain and Israel.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1232-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 19, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 106,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1232-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71382
- Address
- 600 N Field Dr
- Code information
- Lot #: 39-569-DK, Exp 3/1/2016
- Postal code
- 60045-4835
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1232-2015
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 106,900 vials
- Termination date
- Dec 4, 2017
- Reason for recall
- Failed pH Specifications: 12 month stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S. Nationwide, Kuwait, Bahrain and Israel.
- Recall initiation date
- May 19, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2015