Recalls / Class I
Class ID-0668-2016
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 in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.
- Brand name
- Magnesium Sulfate In Water
- Generic name
- Magnesium Sulfate In Water
- Active ingredient
- Magnesium Sulfate Heptahydrate
- Route
- Intravenous
- NDCs
- 0409-2050, 0409-6730, 0409-6729, 0409-4121, 0409-3164, 0409-5239
- FDA application
- NDA020309
- Affected lot / code info
- Lot: 53-113-JT, Exp 1NOV2016
Why it was recalled
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 213,600 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-01-05
- FDA classified
- 2016-02-16
- Posted by FDA
- 2016-02-24
- Terminated
- 2017-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0668-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.