FDA Recall D-1145-2017
Chiavna Saffron LLC · Huntersville, NC
Class I — life-threatening Terminated 249 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
Reason for recall
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Recall record
- Recall number
D-1145-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2017-07-21
- Classified by FDA Center
- 2017-09-12
- FDA published
- 2017-09-20
- Terminated
- 2018-03-27
- Recalling firm
- Chiavna Saffron LLC
- Firm location
- Huntersville, NC