FDA Drug Class I — Most Serious

MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language

Hazard

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

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Products

MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
Brand
A&H Focal Inc.
UPC
All Lots

Units Affected

unknown

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