Multi-event May 2016 FDA Recall Drug by Sos Telecom Inc.

This Multi-event Class I drug recall was voluntarily initiated by Sos Telecom Inc. on May 12, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in NY and the recall is currently terminated.

Reported Recall Events

D-0103-2017 TERMINATED D-0104-2017 TERMINATED D-0101-2017 TERMINATED D-0102-2017 TERMINATED

Recall Number: D-0103-2017

Reason for Recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Initiated
05-12-2016
Reported
10-26-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74144
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.
SOS Telecom Inc.
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-06-2018
Product Description About Product Description
Full technical description of the product.
Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.

Batch or Lot Expiration Information

Lot# Lot: 7788965; Best use by: 10/15/2018

Recall Number: D-0104-2017

Reason for Recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Initiated
05-12-2016
Reported
10-26-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74144
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.
SOS Telecom Inc.
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-06-2018
Product Description About Product Description
Full technical description of the product.
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.

Batch or Lot Expiration Information

Lot# Lot: 7920499; Best use by: 10/15/2016

Recall Number: D-0101-2017

Reason for Recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Initiated
05-12-2016
Reported
10-26-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74144
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.
SOS Telecom Inc.
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-06-2018
Product Description About Product Description
Full technical description of the product.
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box

Batch or Lot Expiration Information

Lot# Lot No: 9236999; Best use by: 12/16/2016

Recall Number: D-0102-2017

Reason for Recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Initiated
05-12-2016
Reported
10-26-2016
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74144
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.
SOS Telecom Inc.
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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-06-2018
Product Description About Product Description
Full technical description of the product.
Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box.

Batch or Lot Expiration Information

Lot# Lot: 7920888; Best Use by: 6/31/2018