FDA Recall D-1333-2022
Distributor RFR, LLC. · Doral, FL
Class I — life-threatening Terminated 1103 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Recall record
- Recall number
D-1333-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela
- Recall initiated
- 2022-07-22
- Classified by FDA Center
- 2022-08-09
- FDA published
- 2022-08-10
- Terminated
- 2025-07-29
- Recalling firm
- Distributor RFR, LLC.
- Firm location
- Doral, FL