D-0229-2016 Class I Ongoing
FDA drug recall D-0229-2016 was initiated by The One Minute Miracle Inc on August 27, 2015 and is designated Class I. 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 unappro… The recall status is ongoing. Affected quantity: 688 cartons.
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