Status
Terminated
Drug Enforcement D-1390-2012
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Classification
Class III
Report Date
June 27, 2012
Termination Date
August 8, 2013
Product Information
- Product description
- 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.
- Product quantity
- 164,568 containers
- Reason for recall
- Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira, Inc.
- Address
-
600 N Field Dr Bldg J45, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1390-2012
- Event ID
- 62053
- Recall initiation date
- April 5, 2012
- Center classification date
- June 20, 2012
- Code info
- Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it
- More code info
- —