Multi-event May 2021 FDA Recall Drug by Miracle 8989
This Multi-event Class I drug recall was voluntarily initiated by Miracle 8989 on May 18, 2021 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda - product found to be tainted with sildenafil and tadalafil.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0635-2021
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
05-18-2021
06-30-2021
Unknown
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Miracle 8989
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
07-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
Recall Number: D-0634-2021
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
05-18-2021
06-30-2021
Unknown
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Miracle 8989
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
07-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
Recall Number: D-0633-2021
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
05-18-2021
06-30-2021
Unknown
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Miracle 8989
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
07-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
