Recalls / Class II

Class IIF-0755-2014

Product

Dietary Supplements packaged in the following configurations: (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939); (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852);

Type

Food

Affected lot / code info

Lot #'s: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, and 53852016

Quantity

16444 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-0755-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.