ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC
Summary
The FDA issued a Class I for ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distribute by Alpha-Tek LLC. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil.
Details
Source
Drug Recall
External ID
D-0001-2022
Action Date
2021-10-13
Status
Ongoing
Category
drug
Product Description
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Lot/Code Info: All lots within expiry
Quantity Affected: Unknown
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-16
Company
Tucson, AZ
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 85 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 (Alpha-Tek LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Alpha-Tek LLC have FDA actions?
This is the only FDA action we have on record for Alpha-Tek LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0001-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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