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Recall Observatory FDA recall evidence

Drug product

Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072

D-1078-2014

November 22, 2013

Class II

Product summary

Firm
Faria Limited LLC dba Sheffield Pharmaceuticals
Event
Event 66962
Status
Terminated
Classification
Class II
Quantity
26424
Official record key
drug-enforcement:D-1078-2014

Official wording

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Code information: 20221 EXP. 04/14

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination