FDA Recall D-0821-2018
AMA Wholesale · Chino Hills, CA
Class I — life-threatening Terminated 1091 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Recall record
- Recall number
D-0821-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the US
- Recall initiated
- 2018-04-12
- Classified by FDA Center
- 2018-05-18
- FDA published
- 2018-05-30
- Terminated
- 2021-04-07
- Recalling firm
- AMA Wholesale
- Firm location
- Chino Hills, CA