D-0633-2021 Class I Terminated
FDA drug recall D-0633-2021 was initiated by Miracle 8989 on May 18, 2021 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. The recall status is terminated (terminated July 12, 2023). Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- June 30, 2021
- Initiation Date
- May 18, 2021
- Termination Date
- July 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Reason for Recall
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Distribution Pattern
USA Nationwide
Code Information
All lots remaining within expiry.