Recalls / Class I
Class ID-1336-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
- Affected lot / code info
- Lot# 20212001, Exp. Date 12/2024
Why it was recalled
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.
Recalling firm
- Firm
- Loud Muscle Science
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 300 Oser Ave, N/A, Hauppauge, New York 11788-3608
Distribution
- Quantity
- 5,421 60-count bottles
- Distribution pattern
- The product was distributed nationwide in the USA and Canada.
Timeline
- Recall initiated
- 2022-06-27
- FDA classified
- 2022-08-15
- Posted by FDA
- 2022-07-27
- Terminated
- 2023-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1336-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.