Faria Limited LLC dba Sheffield Pharmaceuticals: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Agency Publication Date: February 5, 2014

Affected Products

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

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

Product: FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105

20022 EXP. 12/13, 20031 EXP. 12/13, 20032 EXP. 12/13, 20041 EXP. 12/13, 20042 EXP. 12/13, 20051 EXP. 12/13, 20052 EXP. 12/13, 20061 EXP. 12/13, 20071 EXP. 12/13, 20072 EXP. 12/13

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

20221 EXP. 04/14

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66962

Status: Resolved

Manufacturer: Faria Limited LLC dba Sheffield Pharmaceuticals

Manufactured In: United States

Units Affected: 3 products (332508; 147566; 26424)

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Sources: FDA iRES · Raw API Response

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