Recalls / Class II
Class IIF-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 international distribution) (SKU 72106);
- Type
- Food
- Affected lot / 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
- Quantity
- 1827.13 kg of powder
Why it was recalled
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Recalling firm
- Firm
- National Enzyme Co
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10203 State Highway 76, N/A, Forsyth, Missouri 65653-5445
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2013-10-30
- FDA classified
- 2013-12-13
- Posted by FDA
- 2013-12-25
- Terminated
- 2015-03-03
- Status
- Terminated
Source: openFDA Food Enforcement endpoint. Recall record F-0814-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.