Recalls / Class II
Class IIF-0765-2014
Product
Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093);
- Type
- Food
- Affected lot / code info
- Lot #'s: 92093010, 92093011, 92093012, 92093013, 92093014, 92093015, and 92093016
- Quantity
- 2,134,857 bulk capsules
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-0765-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.