Recalls / Class II
Class IID-1076-2014
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
- Brand name
- Sheffield Triple Antibiotic
- Generic name
- Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate
- Active ingredients
- Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
- Route
- Topical
- NDC
- 11527-162
- FDA application
- M004
- Affected lot / code info
- 20154 EXP.12/13, 20153 EXP.12/13, 20152 EXP.12/12, 20151 EXP.12/11, 20093 EXP.12/13, 20092 EXP.12/13, 20091 EXP.12/13, 20085 EXP.12/13, 20084 EXP.12/13, 20083 EXP. 2/13, 20082 EXP.12/13, 20073 EXP. 12/13, 20074 EXP. 12/13, 20075 EXP. 12/13, 20081 EXP.12/13, 20021 EXP. 12/13
Why it was recalled
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Recalling firm
- Firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Manufacturer
- Sheffield Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 170 Broad St, New London, Connecticut 06320-5313
Distribution
- Quantity
- 332508
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-22
- FDA classified
- 2014-02-05
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1076-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.