FDA-Drug2015-11-18Class I
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.
The One Minute Miracle Inc
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.
Sold states
Nationwide
Affected count
688 cartons
Manufactured in
3322 NE 166th St, N/A, North Miami Beach, FL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2016Don't want to check this manually?
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