National Enzyme Co recalls Dietary Supplements packaged in the following configurations: (1) Bulk Isolase-I powder packaged in varying quantities

Recalled December 25, 2013 · FDA recall F-0814-2014 · National Enzyme

Hazard

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

Units

1827.13 kg of powder

Sold at

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.

Description

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

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 international distribution) (SKU 72106);

Manufacturer(s)

National Enzyme Co

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →