D-1076-2014 Class II Terminated
FDA drug recall D-1076-2014 was initiated by Faria Limited LLC dba Sheffield Pharmaceuticals on November 22, 2013 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing The recall status is terminated (terminated June 9, 2014). Affected quantity: 332508.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- November 22, 2013
- Termination Date
- June 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 332508
Product Description
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 Pattern
Nationwide
Code Information
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