D-0625-2018 Class I Terminated
FDA drug recall D-0625-2018 was initiated by Jimmy Weber on March 8, 2018 and is designated Class I. 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. The recall status is terminated (terminated July 26, 2019). Affected quantity: 315 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- April 4, 2018
- Initiation Date
- March 8, 2018
- Termination Date
- July 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315 capsules
Product Description
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.
Distribution Pattern
Product was distributed online via eBay.
Code Information
UPC # 891656002209, exp date 12/31/2021