FDA recall D-315-2013

Hospira Inc. · Class II · drug

Product

QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02

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
2013-02-26
Report date
2013-05-15
Termination date
2014-11-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-315-2013