FDA recall D-1048-2017

Product

Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).

Reason for recall

Lack of Sterility Assurance

Distribution

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Key facts

Status

Terminated

Initiation date

2017-06-15

Report date

2017-08-09

Termination date

2020-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rocky Mount, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1048-2017