SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 291
Summary
The FDA issued a Class I for SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA by Green Pharmaceuticals, Inc.. Reason: Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia ret.
Details
Source
Drug Recall
External ID
D-1165-2022
Action Date
2022-07-06
Status
Terminated
Category
drug
Product Description
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
Lot/Code Info: Lot #: 2373/21222
Quantity Affected: 1074 spray bottles
Reason for Recall
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-09
Company
Camarillo, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Green Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Green Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Green Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1165-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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