FDA recall D-1076-2014

Faria Limited LLC dba Sheffield Pharmaceuticals · Class II · drug

Product

Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320

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-1076-2014