Multi-event January 2014 FDA Recall Drug by Schindele Enterprises Dba Midwest Wholesale

This Multi-event Class I drug recall was voluntarily initiated by Schindele Enterprises Dba Midwest Wholesale on January 9, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI and the recall is currently terminated.

Reported Recall Events

D-1338-2014 TERMINATED D-1339-2014 TERMINATED D-1335-2014 TERMINATED D-1340-2014 TERMINATED D-1337-2014 TERMINATED D-1336-2014 TERMINATED D-1334-2014 TERMINATED

Recall Number: D-1338-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
59/1-ct blister pack, 97/12-ct bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638

Batch or Lot Expiration Information

Lot# 12-ct.bottle, Lot GP808, Exp. 10/16, 1-ct. blister Lot BN030613, EXP 020615

Recall Number: D-1339-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
57 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.

Batch or Lot Expiration Information

Lot# Lot 0512058, Exp. 05/16

Recall Number: D-1335-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
500 1-ct blisters; 30 3-ct bottles, 4 12-ct bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.

Batch or Lot Expiration Information

Lot# 12 pill bottle and 3 pill bottle:
Lot# B70130 Exp. 03/15; 1 pill pack:
Lot# 06012011 Exp 06/14.

Recall Number: D-1340-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
89 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.

Batch or Lot Expiration Information

Lot# Lot 130520PL Exp. 05/31/2017

Recall Number: D-1337-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
49 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.

Batch or Lot Expiration Information

Lot# 1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015.

Recall Number: D-1336-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
2 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.

Batch or Lot Expiration Information

Lot# NO LOT NUMBER, Exp 12/31/14

Recall Number: D-1334-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Initiated
01-09-2014
Reported
05-28-2014
Quantity
175 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67228
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Schindele Enterprises dba Midwest Wholesale
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-03-2015
Product Description About Product Description
Full technical description of the product.
XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.

Batch or Lot Expiration Information

Lot# 130710GL, Exp. 07/31/2018