Recalls / Class I
Class ID-1076-2015
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 IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
- Brand name
- Magnesium Sulfate In Dextrose
- Generic name
- Magnesium Sulfate In Dextrose
- Active ingredient
- Magnesium Sulfate Heptahydrate
- Route
- Intravenous
- NDC
- 0409-6727
- FDA application
- NDA020488
- Affected lot / code info
- Lot: 42-120-JT, Exp 01DEC2015
Why it was recalled
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 181,704 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-06
- FDA classified
- 2015-05-13
- Posted by FDA
- 2015-05-20
- Terminated
- 2016-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1076-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.