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Recall Observatory FDA recall evidence

Drug product

SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.

D-1336-2014

January 09, 2014

Class I

Product summary

Firm
Schindele Enterprises dba Midwest Wholesale
Event
Event 67228
Status
Terminated
Classification
Class I
Quantity
2 blister packs
Official record key
drug-enforcement:D-1336-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

Code information: NO LOT NUMBER, Exp 12/31/14

Distribution pattern: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.