Reported Nov 18, 2015 · Ongoing
MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For:…
The One Minute Miracle Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The One Minute Miracle Inc · 3322 NE 166th St · North Miami Beach, FL · 33160-3844
Is this the product you have?
MIRACLE ROCK 48 capsulespackaged in 2 x 2-count blisters4-count capsules per carton
- Manufactured Exclusively ForThe One Minute Miracle Inc., UPC 0911312397354
- Lot codes and dates
- All lots through Expiration Date 06/01/2018
- Amount recalled
- 688 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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