Drug product
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
D-1165-2022
Product summary
- Event
- Event 90384
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1074 spray bottles
- Official record key
drug-enforcement:D-1165-2022
Official wording
Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Code information: Lot #: 2373/21222
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Microbial contamination
Microbial contamination