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Class I: serious health riskTerminated

Anabolic Science Labs 7-Ment Alpha Advanced Mass Builder Recall

7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 9…

Anabolic Science Labs, LLC · Winter Park, FL

Risk level
Class I
Reported by FDA
May 13, 2015
Recall ID
D-0987-2015
Check your lot numberHow we source this data

Summary

Anabolic Science Labs recalled 7-Ment Alpha Advanced Mass Builder starting Dec 12, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-0987-2015 on May 13, 2015. Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs. Status: Terminated.

Why it was recalled

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Product description

7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

US Nationwide and Singapore

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-0987-2015
Classification
Class I
Status
Terminated
Recall initiated
Dec 12, 2014
FDA report date
May 13, 2015
Quantity
3,808 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Anabolic Science Labs, LLC

Original FDA data

Every field from FDA enforcement report D-0987-2015, exactly as published.

Show all FDA fields
City
Winter Park
State
FL
Status
Terminated
Country
United States
Event ID
70317
Address
900 S Kentucky Ave
Code information
All lots
Postal code
32789-4751
Report date
May 13, 2015
Product type
Drugs
Recall number
D-0987-2015
Classification
Class I
Recalling firm
Anabolic Science Labs, LLC
Product quantity
3,808 bottles
Termination date
Feb 8, 2017
Reason for recall
Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Voluntary / mandated
Voluntary: Firm initiated
Product description
7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
Distribution pattern
US Nationwide and Singapore
Recall initiation date
Dec 12, 2014
Initial firm notification
Press Release
Center classification date
May 5, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0987-2015, published May 13, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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