FDA recall D-604-2013

Faria Limited LLC dba Sheffield Pharmaceuticals · Class III · drug

Product

Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g)

Reason for recall

Failed Stability Specifications: Unable to meet shelf life expiry.

Distribution

PA, GA, WA, CA

Key facts

Status: Terminated
Initiation date: 2013-05-28
Report date: 2013-06-26
Termination date: 2014-03-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: New London, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-604-2013