D-0353-2021 Class II Ongoing
FDA drug recall D-0353-2021 was initiated by Na Na Collection on March 30, 2021 and is designated Class II. Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- March 30, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Distribution Pattern
Nationwide with the United States
Code Information
Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856