FDA recall F-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;

Reason for recall

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Distribution

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.

Key facts

Status

Terminated

Initiation date

2013-10-30

Report date

2013-12-25

Termination date

2015-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Forsyth, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0747-2014