Recalls / Class II
Class IIF-0739-2014
Product
Dietary Supplements packaged in the following configurations: (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX; (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles; (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label; (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL; (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL. (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
- Type
- Food
- Affected lot / code info
- Lot Numbers: 52413126, 52413128, 52413129, 52413130, 52413131, 52413132, 52413133, 52413134, 52413138, 52520124, 52520126, 52520127, 52520128, 52520129, 52520130, 52520131, 52520135, 53098131, 53098133, 53098134, 53098135, 53098136, 53098137, 53098138, 53098139, 53098141, 53098145, 53571110, 53571111, 53571112, 53571116, 54599000, 54646000, 54646001, 54646005, 54752000, 54914002, 92494001, and 92494002
- Quantity
- 44288 bottles, 6781 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-0739-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings.