Recalls / Class I
Class ID-1137-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Affected lot / code info
- Lot #: 50-343-DK*, Exp 01FEB2017; note that the lot number may be followed by numbers from 01 to 99.
Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 88,500 vials
- Distribution pattern
- Nationwide, United Arab Emirates, Kuwait, and Bahrain
Timeline
- Recall initiated
- 2016-03-23
- FDA classified
- 2016-07-06
- Posted by FDA
- 2016-07-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1137-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.