FDA recall F-0750-2014

National Enzyme Co · Class II · food

Product

Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.; (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799);

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-0750-2014