D-1143-2017 Class I Terminated
FDA drug recall D-1143-2017 was initiated by Andropharm, LLC on June 6, 2017 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids. The recall status is terminated (terminated June 2, 2020). Affected quantity: 1250 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- June 6, 2017
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1250 bottles
Product Description
ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
Reason for Recall
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Distribution Pattern
Florida
Code Information
All lots remaining within expiry.