FDA Recall D-1165-2022
Green Pharmaceuticals, Inc. · Camarillo, CA
Class I — life-threatening Terminated 309 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
Reason for recall
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Recall record
- Recall number
D-1165-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide within the United States
- Recall initiated
- 2022-06-09
- Classified by FDA Center
- 2022-06-27
- FDA published
- 2022-07-06
- Terminated
- 2023-04-14
- Recalling firm
- Green Pharmaceuticals, Inc.
- Firm location
- Camarillo, CA