Recalls / Class II
Class IIF-0810-2014
Product
PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label;
- Type
- Food
- Affected lot / code info
- Lot #'s: 54825002 and 54826002
- Quantity
- 653 bottles
Why it was recalled
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Recalling firm
- Firm
- National Enzyme Co
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10203 State Highway 76, N/A, Forsyth, Missouri 65653-5445
Distribution
- Distribution pattern
- Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.
Timeline
- Recall initiated
- 2013-10-30
- FDA classified
- 2013-12-13
- Posted by FDA
- 2013-12-25
- Terminated
- 2015-03-03
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0810-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.