Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Undeclared Tadalafil
- Company Name:
- Junp LLC
- Brand Name:
- Product Description:
-
Product Description
MegMan Performance Booster capsules
Company Announcement
FOR IMMEDIATE RELEASE – 2/3/2022– Brooklyn, NY Junp LLC is voluntarily recalling Lot number 2010291, Exp Date: 01/07/2024 of MegMan Performance Booster capsules, packaged in 10-count blisters packaged in a carton to the consumer level. Junp LLC was notified by Amazon that laboratory analysis has found the product to be tainted with Tadalafil. Tadalafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in MegMan Performance Booster makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take MegMan Performance Booster Capsules with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Junp LLC has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10 count blisters packaged in a carton, UPC 8 48998 0091 2. The affected lot number of MegMan performance booster include Lot # 2010291, Exp Date 01/07/2024. MegMan Performance Booster was distributed via internet and fulfilled by Amazon from 11/10/2021 till 12/27/2021 at www.amazon.com nationwide in the USA. On December 17, 2022, FDA issued a press release that warned consumers to avoid certain products founds on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encourages online marketplaces to ensure these products are not sold on their platforms.
Junp LLC is notifying its distributors and customers by Amazon Messaging and is arranging return of all recalled products. Consumers that have MegMan Performance Booster which is being recalled should stop using the product.
Consumers with questions regarding this recall can contact Junp LLC by phone: 929-559-4706 or by email: [email protected] on Monday-Friday 9:00AM to 5:00PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
