FDA Recall D-0557-2022
Junp Hydration LLC · Brooklyn, NY
Class I — life-threatening Terminated 125 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
Reason for recall
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall record
- Recall number
D-0557-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Product was distributed nationwide in the USA via Amazon Marketplace
- Recall initiated
- 2022-02-04
- Classified by FDA Center
- 2022-02-11
- FDA published
- 2022-02-16
- Terminated
- 2022-06-09
- Recalling firm
- Junp Hydration LLC
- Firm location
- Brooklyn, NY