Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);
FDA recall notice · announced December 25, 2013 · National Enzyme Co
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);
Reason for recall
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Notes
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.
Lot/code information: Lot #: 83377001
Quantity: 25.9 kg of powder
Status: Terminated
Products in this recall event:
- Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115). (F-0771-2014)
- Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103). (F-0767-2014)
- Dietary Supplements packaged in the following configurations: (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274); (2) Bulk 6916 WE (F-0753-2014)
- Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN; (F-0760-2014)
- Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438 (F-0809-2014)
- Dietary Supplements packaged in the following configuration: (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Mon (F-0784-2014)
- Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566) (F-0756-2014)
- 4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export. (F-0743-2014)
- Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544); (F-0802-2014)
- Dietary Supplements packaged in the following configurations: (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO; (2) C5 (F-0803-2014)
- enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles. (F-0740-2014)
- Dietary Supplement packaged in the following configurations: (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027); (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 c (F-0746-2014)
- Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314 (F-0783-2014)
- Dietary Supplements packaged in the following configurations: (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industri (F-0759-2014)
- Dietary Supplements packaged in the following configurations: (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC; ( (F-0754-2014)
- Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (F-0775-2014)
- Dietary Supplements packaged in the following configurations: (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bell (F-0799-2014)
- Dietary Supplement Formula ID B859; Packaged in the following configuration: B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112); (F-0790-2014)
- Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466) (F-0813-2014)
- WELLZYMES, Digestive Health, Enzyme Supplement packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO (F-0741-2014)
- Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83 (F-0808-2014)
- PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label; (F-0810-2014)
- 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 dru (F-0814-2014)
- WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO. (F-0749-2014)
- Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056); (F-0764-2014)
- Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419 (F-0800-2014)
- Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 9243 (F-0796-2014)
- Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408 (F-0793-2014)
- Dietary Supplements packaged in the following configurations: (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939); (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unla (F-0755-2014)
- 8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854) (F-0757-2014)
- Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company; (F-0801-2014)
- Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO; (F-0780-2014)
- Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461) (F-0758-2014)
- Dietary Supplements packaged in the following configurations: (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). (F-0806-2014)
- 3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814 (F-0738-2014)
- Dietary Supplement Formula ID A200; Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (F-0776-2014)
- Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO (F-0737-2014)
- 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 530 (F-0739-2014)
- 9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666); (F-0762-2014)
- Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033); (F-0763-2014)
- Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (F-0778-2014)
- Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, (F-0750-2014)
- Dietary Supplement packaged in the following configurations: (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (F-0747-2014)
- Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403 (F-0797-2014)
- WELLZYMES, Gastric Ease, Enzyme Supplement packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO (F-0742-2014)
- Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453 (F-0812-2014)
- Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381) (F-0791-2014)
- Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is (F-0734-2014)
- Dietary Supplements packaged in the following configuration: (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is Na (F-0785-2014)
- 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); (F-0765-2014)
- Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085). (F-0769-2014)
- NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, (F-0773-2014)
- IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT; (F-0795-2014)
- B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255); (F-0792-2014)
- Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA; (F-0798-2014)
- Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (F-0774-2014)
- TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR; (F-0788-2014)
- ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO (F-0736-2014)
- IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT; (F-0794-2014)
- Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318 (F-0782-2014)
- Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (F-0779-2014)
- DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL (F-0766-2014)
- Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000) (F-0807-2014)
- Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN; (F-0805-2014)
- 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 distri (F-0787-2014)
- Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342). (F-0786-2014)
- Dietary Supplement packaged in the following configurations: (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.; (2) 6379 Kir (F-0751-2014)
- Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101). (F-0770-2014)
- Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on t (F-0744-2014)
- Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993); (F-0761-2014)
- Dietary Supplement packaged in the following configuration: (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. T (F-0735-2014)
- Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131). (F-0772-2014)
- Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (F-0777-2014)
- NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.; (F-0748-2014)
- Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103). (F-0768-2014)
- Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287 (F-0781-2014)
- Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA; (F-0811-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.