Terminated Class II

National Enzyme Co

Recall F-0739-2014 · Forsyth, MO

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)

Reason for recall

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

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.

Quantity affected

44288 bottles, 6781 bulk capsules;

Recall type

Voluntary: Firm initiated

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

Timeline

30 Oct 2013 initiated 13 Dec 2013 classified 25 Dec 2013 reported 3 Mar 2015 terminated

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