FDA recall D-308-2013

Hospira Inc. · Class II · drug

Product

Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12

Reason for recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2012-08-28
Report date: 2013-05-08
Termination date: 2014-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-308-2013