June 2022 FDA Recall Drug by Green Pharmaceuticals, Inc.
D-1165-2022 - Microbial contamination of non-sterile product
This Class I drug recall was voluntarily initiated by Green Pharmaceuticals, Inc. on June 9, 2022 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1165-2022
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
06-09-2022
07-06-2022
1074 spray bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Green Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-14-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
Batch or Lot Expiration Information
Lot# : 2373/21222
