Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
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 #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
Where it was sold
Nationwide, United Arab Emirates, Kuwait, and Bahrain
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-1137-2016
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Mar 23, 2016
- FDA report date
- Jul 13, 2016
- Quantity
- 88,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1137-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 73855
- Address
- 275 N Field Dr
- Code information
- Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
- Postal code
- 60045-2579
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1137-2016
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 88,500 vials
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
- 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, United Arab Emirates, Kuwait, and Bahrain
- Recall initiation date
- Mar 23, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2016