FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLA...

FDA Recall #D-1077-2014 — Class II — November 22, 2013

Recall #D-1077-2014 Date: November 22, 2013 Classification: Class II Status: Terminated

Product Description

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

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

147566

Distribution

Nationwide

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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