Drug recall D-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
Reason for recall
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Lots and codes
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
Recall details
- Recalling firm
- Faria Limited LLC dba Sheffield Pharmaceuticals, New London, CT
- Quantity
- 332508
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 22, 2013
- Terminated
- June 9, 2014
Related products
- Sheffield Triple Antibiotic – drug information
- NDC 11527-162 Sheffield Triple Antibiotic · Bacitracin Zinc 400 [USP'U]/g; Polymyxin B Sulfate 5000… · Sheffield Pharmaceuticals LLC
- NDC 11527-163 Sheffield Bacitracin Zinc · Bacitracin Zinc 500 [USP'U]/g · Sheffield Pharmaceuticals LLC