MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Summary
The FDA issued a Class I for MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63 by ABC Sales 1 Inc. Reason: Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products.
Details
Source
Drug Recall
External ID
D-0563-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Lot/Code Info: Lot # 1230005, Exp. date 03/30/2024
Quantity Affected: 336 cartons
Reason for Recall
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-08
Company
Monsey, NY
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 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
ABC Sales 1 Inc has 2 FDA actions in our database, including 2 recalls.
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 (ABC Sales 1 Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ABC Sales 1 Inc have FDA actions?
ABC Sales 1 Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0563-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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