Why it was recalled
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Product description
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
Lot numbers, UPCs & expiration codes
1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.
Where it was sold
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
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-1337-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 9, 2014
- FDA report date
- May 28, 2014
- Quantity
- 49 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Schindele Enterprises dba Midwest Wholesale
Original FDA data
Every field from FDA enforcement report D-1337-2014, exactly as published.
Show all FDA fields
- City
- Nixa
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 67228
- Address
- 617 N Althea Ave
- Code information
- 1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.
- Postal code
- 65714-7432
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1337-2014
- Classification
- Class I
- Recalling firm
- Schindele Enterprises dba Midwest Wholesale
- Product quantity
- 49 blister packs
- Termination date
- Feb 3, 2015
- Reason for recall
- Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.
- Distribution pattern
- Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
- Recall initiation date
- Jan 9, 2014
- Initial firm notification
- Press Release
- Center classification date
- May 20, 2014