Recalls / Class II
Class IID-1077-2014
Product
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
- Affected lot / code info
- 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
Why it was recalled
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Recalling firm
- Firm
- Faria Limited LLC dba Sheffield Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 170 Broad St, New London, Connecticut 06320-5313
Distribution
- Quantity
- 147566
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-22
- FDA classified
- 2014-02-05
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1077-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.