The Recall Desk
SevereFDA (Drugs)·D-1142-2017·Announced 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).

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

Andropharm, LLC is recalling 150 bottles of Andropharm Sten Z capsules. The product is packaged in 60-count bottles and contains 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. The recall covers all lots remaining within their expiry dates.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product label states that it contains anabolic steroids.

The affected product was distributed in Florida. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

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
Manufacturer
Andropharm, LLC
Affected units
150

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Andropharm, LLC 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 2 products in this recall →

Same manufacturer · Andropharm, LLC

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