FDAAugust 27, 2015drug
MIRACLE 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
What to do
FDA enforcement status: Ongoing
Brands named
one minute miracleoneone minute
UPCs
0911312397354
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPremierZEN 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 900062021-05-18
- 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
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