FDA Food Recalls

Recalls / Class II

Class IIF-0158-2014

Product

Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521

Type
Food
Affected lot / code info
Lot F3994
Quantity
27,480

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-0158-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.