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National Enzyme Co
FDA recall F-0814-2014 · Class II · reported 2013-12-25 · Terminated
- 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);
- Reason
- Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
- Quantity
- 1827.13 kg of powder
- 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.
- Firm location
- MO, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2013-10-30
- Terminated
- 2015-03-03
- Code info
- Lot #'s: 71453155, 72073003, 72073004, 71453148, 71453138, 71453142, 71453143, 71453144, 71453137, 71453139, 71453145, 71453146, 71453147, 71453149, 71453152, 71453153, 71453156, 72106012, 72106013, 72106014, 72106015, 72106018, 72106019, 72106020, 72106021, 72106022, 72106024, 72106025, 71453141, 71453154, 72077001, 72080006, 72080007, 72080008, and 72080009
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.