FDA recall D-1390-2012

Hospira, Inc. · Class III · drug

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.

Reason for recall

Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-04-05
Report date: 2012-06-27
Termination date: 2013-08-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1390-2012