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Recall Observatory FDA recall evidence

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

November 22, 2013

Class II

Product summary

Firm
Faria Limited LLC dba Sheffield Pharmaceuticals
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

    reason.microbial_contamination · v1.0.0

    Microbial Contamination