Recalls / Class III
Class IIID-604-2013
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)
- Affected lot / code info
- Lot # 10301, Exp 05/14 Lot # 10302, Exp 05/14
Why it was recalled
Failed Stability Specifications: Unable to meet shelf life expiry.
Recalling firm
- Firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 170 Broad St, New London, Connecticut 06320-5313
Distribution
- Quantity
- 105,744 tubes
- Distribution pattern
- PA, GA, WA, CA
Timeline
- Recall initiated
- 2013-05-28
- FDA classified
- 2013-06-14
- Posted by FDA
- 2013-06-26
- Terminated
- 2014-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-604-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.