FDA recall D-1428-2015

Pharmedium Services, LLC · Class II · drug

Product

Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48

Reason for recall

Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.

Distribution

VA, IL, PA, ID

Key facts

Status: Terminated
Initiation date: 2015-07-21
Report date: 2015-09-16
Termination date: 2015-09-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1428-2015