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Recall Observatory FDA recall evidence

Drug product

ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4

D-1143-2017

June 06, 2017

Class I

Product summary

Firm
Andropharm, LLC
Event
Event 77664
Status
Terminated
Classification
Class I
Quantity
1250 bottles
Official record key
drug-enforcement:D-1143-2017

Official wording

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

Code information: All lots remaining within expiry.

Distribution pattern: Florida

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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