Home / Recalls / The One Minute Miracle Inc / D-0229-2016

D-0229-2016 Class I Ongoing

Recalled by The One Minute Miracle Inc — North Miami Beach, FL

Recall Details

Product Type: Drugs
Report Date: November 18, 2015
Initiation Date: August 27, 2015
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 688 cartons

Product Description

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 Pattern

Nationwide

Code Information

All lots through Expiration Date 06/01/2018