FDA Food Recalls

Recalls / Class II

Class IIF-0159-2014

Product

Klaire Labs Vital-Zymes Chewable; Comprehensive Enzyme Supplement; 180 Chewable tablets. UPC 7 09616 0218 5 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521

Type
Food
Affected lot / code info
Lot F3990 and C3516
Quantity
82,746 lot F3990 and 988.200 of lot C3516.

Why it was recalled

ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.

Recalling firm

Firm
ProThera, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
10439 Double R Blvd, Reno, Nevada 89521-8905

Distribution

Distribution pattern
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.

Timeline

Recall initiated
2013-10-10
FDA classified
2013-11-12
Posted by FDA
2013-11-20
Terminated
2014-02-24
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0159-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.