FDA Recall D-0662-2021
Ummzy, LLC · Palisades Park, NJ
Class I — life-threatening Terminated 436 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
Reason for recall
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Recall record
- Recall number
D-0662-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- USA Nationwide
- Recall initiated
- 2021-03-30
- Classified by FDA Center
- 2021-07-16
- FDA published
- 2021-07-28
- Terminated
- 2022-06-09
- Recalling firm
- Ummzy, LLC
- Firm location
- Palisades Park, NJ