The Recall Desk
SevereFDA (Drugs)·D-1337-2014·Announced 2014-05-28

MiracleZEN Platinum Recalled for Undeclared Sildenafil and Tadalafil

Schindele Enterprises is recalling MiracleZEN Platinum dietary supplements because they contain undeclared sildenafil and tadalafil, which were marketed without FDA approval.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.

Plain-English summary

Schindele Enterprises dba Midwest Wholesale is recalling 49 blister packs of MiracleZEN Platinum, a 2000 mg capsule dietary supplement. The product was distributed by Power Life Distributors and COK Inc. in Los Angeles, California.

The recall was initiated because the dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. These ingredients were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The affected products include 1 pill blister packs with Lot OAWF 1027 and Lot OAWF1003, both with an expiration date of 01/31/2015. The products were distributed to Pennsylvania, Illinois, Texas, Iowa, Georgia, Connecticut, Florida, California, Louisiana, New York, Maryland, Nevada, and Wisconsin. Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Affected units
49

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 7 recalled by Schindele Enterprises dba Midwest Wholesale under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Schindele Enterprises dba Midwest Wholesale

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