Recalls / Class III
Class IIID-1390-2012
Product
Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, 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 #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
Why it was recalled
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Recalling firm
- Firm
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr Bldg J45, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 164,568 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-05
- FDA classified
- 2012-06-20
- Posted by FDA
- 2012-06-27
- Terminated
- 2013-08-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1390-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.