FDA recall D-1078-2014

Faria Limited LLC dba Sheffield Pharmaceuticals · Class II · drug

Product

Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072

Reason for recall

Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-11-22
Report date
2014-02-12
Termination date
2014-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
New London, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1078-2014