Multi-event June 2022 FDA Recall Drug by Loud Muscle Science
This Multi-event Class II drug recall was voluntarily initiated by Loud Muscle Science on June 27, 2022 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1341-2022
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
06-27-2022
07-27-2022
1500 4-count tins
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Batch or Lot Expiration Information
Lot# C07172101, Exp date: 07/2024
Recall Number: D-1338-2022
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
06-27-2022
07-27-2022
500 4-count tins
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Batch or Lot Expiration Information
Lot# 2022104, exp. date 04/2025
Recall Number: D-1337-2022
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
06-27-2022
07-27-2022
1000 10-count tins
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Batch or Lot Expiration Information
Lot# 2022104, Exp. Date 04/2025
Recall Number: D-1339-2022
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
06-27-2022
07-27-2022
2,495 60-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Batch or Lot Expiration Information
Lot# C07172101, Exp date: 07/2024; 2022054, Exp date: 03/2025
Recall Number: D-1336-2022
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
06-27-2022
07-27-2022
5,421 60-count bottles
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Batch or Lot Expiration Information
Lot# 20212001, Exp. Date 12/2024
Recall Number: D-1340-2022
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
06-27-2022
07-27-2022
1500 10-count tins
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Loud Muscle Science
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.
The product was distributed nationwide in the USA and Canada.
02-08-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Batch or Lot Expiration Information
Lot# C07172101, Exp date: 07/2024.
