Multi-event December 2019 FDA Recall Drug by Motto International Corp

This Multi-event Class I drug recall was voluntarily initiated by Motto International Corp on December 17, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; fda analysis found product to contain tadalfil. The product was distributed in TX and the recall is currently terminated.

Reported Recall Events

D-0656-2020 TERMINATED D-0657-2020 TERMINATED D-0655-2020 TERMINATED D-0654-2020 TERMINATED

Recall Number: D-0656-2020

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Initiated
12-17-2019
Reported
01-22-2020
Quantity
5 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84526
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.
Motto International Corp
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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2021
Product Description About Product Description
Full technical description of the product.
Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,white,blue,gray text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-0657-2020

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Initiated
12-17-2019
Reported
01-22-2020
Quantity
1 box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84526
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.
Motto International Corp
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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2021
Product Description About Product Description
Full technical description of the product.
Panther Platinum 30000 Capsules, in green, black background with white, red text in hologram paper packaging, packaged in 2, 4, and 10 count blister cards, Motto International, Dallas, TX

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-0655-2020

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Initiated
12-17-2019
Reported
01-22-2020
Quantity
7 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84526
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.
Motto International Corp
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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2021
Product Description About Product Description
Full technical description of the product.
Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-0654-2020

Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Initiated
12-17-2019
Reported
01-22-2020
Quantity
8 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84526
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.
Motto International Corp
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.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-29-2021
Product Description About Product Description
Full technical description of the product.
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 10 count blister cards, Motto International, Dallas, TX

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.