Why it was recalled
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Product description
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Lot numbers, UPCs & expiration codes
Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
Where it was sold
Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
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-0854-2016
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Mar 23, 2016
- FDA report date
- May 25, 2016
- Quantity
- 715,200 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0854-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 73681
- Address
- 275 N Field Dr
- Code information
- Lot #: 42-335-DK, Exp 1JUN2016; 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, Exp 1DEC2016; 52-361-DK, Exp 1APR2017; note that the lot number may be followed by numbers from 01 to 99.
- Postal code
- 60045-2579
- Report date
- May 25, 2016
- Product type
- Drugs
- Recall number
- D-0854-2016
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 715,200 vials
- Reason for recall
- Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Distribution pattern
- Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
- Recall initiation date
- Mar 23, 2016
- Initial firm notification
- Letter
- Center classification date
- May 16, 2016