X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Summary
The FDA issued a Class I for X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 4 by Phe Inc. Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil..
Details
Source
Drug Recall
External ID
D-0819-2021
Action Date
2021-09-29
Status
Completed
Category
drug
Product Description
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Lot/Code Info: All lots, Exp. 12/2025
Quantity Affected: 15000 packets
Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-18
Company
Hillsborough, NC
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 42 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 (Phe Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Phe Inc have FDA actions?
This is the only FDA action we have on record for Phe Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0819-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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