FDA recall F-0814-2014

Product

Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453); (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073); (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077); (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080); (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for intern

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-0814-2014