Recalls / Class II

Class IIF-0747-2014

Product

Dietary Supplement packaged in the following configurations: (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR; (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;

Type

Food

Affected lot / code info

Lot #'s: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 52588051, 53853006, 53853007, 53853008, 53853009, 53853010, and 54956000

Quantity

16733 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-0747-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.