Drug product
Entertainer's Secret Throat Relief, 2.0 FL oz (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN
D-0328-2015
Product summary
- Event
- Event 70084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,348 / 2 oz. bottles
- Official record key
drug-enforcement:D-0328-2015
Official wording
Reason: Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli
Code information: Lot No. 141010, Best By Date: 10/2016; UPC Code: 728409847025
Distribution pattern: NY and IN.
Derived failure modes
-
Microbial contamination
Microbial Contamination