Drug product
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105
D-1077-2014
Product summary
- Event
- Event 66962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147566
- Official record key
drug-enforcement:D-1077-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination