The Recall Desk

FDA (Drugs) recall action 77664

Andropharm, LLC recalled 2 products on 2017-09-20

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
2017-09-20
Critical
0
Units
1,400

Why these products were recalled

Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2017-09-20

    Andropharm M1 Alpha capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 1,250 bottles of M1 Alpha capsules sold in Florida because the product was marketed without an approved NDA or ANDA.

    Product
    ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-09-20

    Andropharm Sten Z capsules recalled for lack of FDA approval

    Andropharm, LLC is recalling 150 bottles of Andropharm Sten Z capsules because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydroxy-2a, 17b-dimethyl-5a-androstan-3-one azine 10 mg) capsule, packaged in 60-count bottle, Andropharm.com, UPC: 6 42125 50294 8
    Category
    Distribution
    1 state