FDAMay 18, 2021drug
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
What to do
FDA enforcement status: Terminated
Brands named
miracle 8989miracle
UPCs
728175421856728175421832
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAmaXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 900282021-05-18
- FDAPremierZEN 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 900062021-05-18
- CPSCMiracle Botanicals Recalls Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)2020-07-09
- CPSCL.L. Bean Recalls Toddler Sweater Fleece Pullovers Due to Choking Hazard (Recall Alert)2017-09-07
- FDAMIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.2015-08-27
- FDAMIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.2015-08-27
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