Recalls / Class I
Class IF-1879-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.
Product
Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA.
- Type
- Food
- Affected lot / code info
- lot # PB0091512, exp. date 8/2014, UPC code 283333900111
- Quantity
- 600
Why it was recalled
The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label.
Recalling firm
- Firm
- Reaction Nutrition LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 230 E Main St, N/A, Carnegie, Pennsylvania 15106-2700
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-11-07
- FDA classified
- 2013-09-10
- Posted by FDA
- 2013-09-18
- Terminated
- 2014-08-26
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-1879-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings.