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Class I: serious health riskTerminated

Schindele Enterprises dba Midwest Wholesale Xzen Platinum Recall

XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA

Schindele Enterprises dba Midwest Wholesale · Nixa, MO

Risk level
Class I
Reported by FDA
May 28, 2014
Recall ID
D-1340-2014
Check your lot numberHow we source this data

Summary

Schindele Enterprises dba Midwest Wholesale recalled Xzen Platinum starting Jan 9, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-1340-2014 on May 28, 2014. Reason: Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Status: Terminated.

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

XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.

Lot numbers, UPCs & expiration codes

Lot 130520PL Exp. 05/31/2017

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-1340-2014
Classification
Class I
Status
Terminated
Recall initiated
Jan 9, 2014
FDA report date
May 28, 2014
Quantity
89 blister packs
Recall type
Voluntary: Firm initiated
Recalling firm
Schindele Enterprises dba Midwest Wholesale

Original FDA data

Every field from FDA enforcement report D-1340-2014, 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
Lot 130520PL Exp. 05/31/2017
Postal code
65714-7432
Report date
May 28, 2014
Product type
Drugs
Recall number
D-1340-2014
Classification
Class I
Recalling firm
Schindele Enterprises dba Midwest Wholesale
Product quantity
89 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
XZEN PLATINUM, 750 mg, Distributed by: XZEN, 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1340-2014, published May 28, 2014. 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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