The Recall Desk

FDA (Drugs) recall action 87712

NSNY Distributor Inc recalled 2 products on 2021-07-07

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-07-07
Critical
2
Units
2,999

Why these products were recalled

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • CriticalFDA (Drugs)··2021-07-07

    Premium OrgaZEN 7000 Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Premium OrgaZEN 7000 capsules distributed nationwide have been recalled because they were marketed without FDA approval and contain undeclared sildenafil and/or tadalafil, prescription drugs that pose serious health risks.

    Product
    Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2021-07-07

    Ginseng Power 5000 Capsules Recalled for Undeclared Prescription Drug Ingredients

    NSNY Distributor Inc is recalling Ginseng Power 5000 capsules nationwide because they contain undeclared sildenafil and/or tadalafil, prescription medications not listed on the label or approved for sale in this product.

    Product
    Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
    Category
    Distribution
    0 states