Why it was recalled
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Product description
METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
Lot numbers, UPCs & expiration codes
lot number: L54Q
Where it was sold
Nationwide
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-1151-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 22, 2013
- FDA report date
- Mar 12, 2014
- Quantity
- 5,555 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mira Health Products Ltd.
Original FDA data
Every field from FDA enforcement report D-1151-2014, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 65772
- Address
- 65 E Carmans Rd
- Code information
- lot number: L54Q
- Postal code
- 11735-3834
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1151-2014
- Classification
- Class I
- Recalling firm
- Mira Health Products Ltd.
- Product quantity
- 5,555 bottles
- Termination date
- Sep 15, 2014
- Reason for recall
- Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 22, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 5, 2014