FDA recall D-0125-2017

Pharmedium Services, LLC · Class II · drug

Product

Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.

Reason for recall

Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-10-12
Report date
2016-11-09
Termination date
2016-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0125-2017