Why it was recalled
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Product description
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Lot numbers, UPCs & expiration codes
All lots
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-0220-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 29, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 1000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Making It a Lifestyle
Original FDA data
Every field from FDA enforcement report D-0220-2017, exactly as published.
Show all FDA fields
- City
- Corpus Christi
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 73973
- Address
- 6202 Beechwood Dr
- Code information
- All lots
- Postal code
- 78412-4744
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0220-2017
- Classification
- Class I
- Recalling firm
- Making It a Lifestyle
- Product quantity
- 1000 bottles
- Termination date
- Sep 30, 2020
- Reason for recall
- Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 29, 2016
- Initial firm notification
- Press Release
- Center classification date
- Dec 22, 2016