FDA recall D-0985-2017

PharMedium Services, Llc · Class II · drug

Product

Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65

Reason for recall

Lack of Assurance of Sterility; media fill failure at manufacturer

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-06-26
Report date
2017-07-26
Termination date
2020-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0985-2017