Recalls / Class II
Class IIF-0787-2014
Product
Dietary Supplements packaged in the following configurations: (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275); (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.
- Type
- Food
- Affected lot / code info
- Lot #'s: 92275001, 92275003, and 54955000
- Quantity
- 321,893 bulk capsules, 3714 bottles.
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-0787-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.