Why it was recalled
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Product description
ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Florida
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1143-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 6, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 1250 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Andropharm, LLC
Original FDA data
Every field from FDA enforcement report D-1143-2017, exactly as published.
Show all FDA fields
- City
- Boca Raton
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77664
- Address
- 1140 Holland Dr
- Address (line 2)
- Ste 12
- Code information
- All lots remaining within expiry.
- Postal code
- 33487-2764
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1143-2017
- Classification
- Class I
- Recalling firm
- Andropharm, LLC
- Product quantity
- 1250 bottles
- Termination date
- Jun 2, 2020
- Reason for recall
- Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packaged in 60-count bottle, Amazon.com, UPC 6 42125 50292 4
- Distribution pattern
- Florida
- Recall initiation date
- Jun 6, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2017