Why it was recalled
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Product description
Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
Lot numbers, UPCs & expiration codes
lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown
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-1150-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 22, 2013
- FDA report date
- Mar 12, 2014
- Quantity
- 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mira Health Products Ltd.
Original FDA data
Every field from FDA enforcement report D-1150-2014, 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 numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown
- Postal code
- 11735-3834
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1150-2014
- Classification
- Class I
- Recalling firm
- Mira Health Products Ltd.
- Product quantity
- 11,200 bottles (60 capsules per bottle) (quantities for E07Q unknown)
- Termination date
- Sep 15, 2014
- Reason for recall
- Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
- 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