FDA Recall D-0625-2018
Jimmy Weber · Los Angeles, CA
Class I — life-threatening Terminated 505 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Recall record
- Recall number
D-0625-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Product was distributed online via eBay.
- Recall initiated
- 2018-03-08
- Classified by FDA Center
- 2018-04-11
- FDA published
- 2018-04-04
- Terminated
- 2019-07-26
- Recalling firm
- Jimmy Weber
- Firm location
- Los Angeles, CA