Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (...
FDA Recall #D-1076-2014 — Class II — November 22, 2013
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
Recalling Firm
Faria Limited LLC dba Sheffield Pharmaceuticals — New London, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
332508
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated