FDA recall D-0229-2016

Product

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.

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2015-08-27

Report date

2015-11-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Miami Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2016