Drug 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
D-1076-2014
Product summary
- Event
- Event 66962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 332508
- Official record key
drug-enforcement:D-1076-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination