Recalls / Class I
Class ID-0973-2016
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
Xcellerator (product not labeled)
- Affected lot / code info
- unknown
Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recalling firm
- Firm
- Novacare, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 312 W 6100 S, N/A, Murray, Utah 84107-6990
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-24
- FDA classified
- 2016-06-06
- Posted by FDA
- 2016-06-15
- Terminated
- 2017-08-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0973-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.