FDA Recall D-0819-2021
Phe Inc · Hillsborough, NC
Class I — life-threatening Completed 1730 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Recall record
- Recall number
D-0819-2021- Classification
- Class I
- Status
- Completed
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide within the United States
- Recall initiated
- 2021-08-18
- Classified by FDA Center
- 2021-09-21
- FDA published
- 2021-09-29
- Recalling firm
- Phe Inc
- Firm location
- Hillsborough, NC