FDA Recall D-0229-2016

The One Minute Miracle Inc · North Miami Beach, FL

Class I — life-threatening Ongoing 3913 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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.

Lot / code: All lots through Expiration Date 06/01/2018

Quantity: 688 cartons

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.

Recall record

Recall number: D-0229-2016
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2015-08-27
Classified by FDA Center: 2015-11-12
FDA published: 2015-11-18
Recalling firm: The One Minute Miracle Inc
Firm location: North Miami Beach, FL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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