Important Recall Information: A number of natural health products potentially contaminated with chloramphenicol may pose serious health risks to consumers

Starting date:
October 18, 2013
Posting date:
October 18, 2013
Type of communication:
Information Update
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Contamination
Audience:
General Public
Identification number:
RA-36355

Issue

Health Canada wishes to inform Canadians that additional natural health products (see chart below) are being voluntarily recalled by a number of Canadian companies due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers.

Specialty Enzymes & Biotechnologies has provided contaminated raw materials to a number of companies producing natural health products for the Canadian market. As a result, natural health products from these companies are at risk of contamination with chloramphenicol.

The only products Health Canada is currently aware of potentially being contaminated are products used as digestive and menopausal aids. Health Canada is working with Specialty Enzymes & Biotechnologies and its Canadians customers to confirm affected products and will continue to provide updates to Canadians as warranted.

Chloramphenicol is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol.  

Chloramphenicol is a prescription drug and should only be used under medical supervision in adults and children after careful consideration of the risks associated with its use. Other side effects that can be associated with chloramphenicol include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. In addition, it should not be used by pregnant or lactating women.

Canadians can monitor the table below for additions to the list of products potentially contaminated with chloramphenicol that may pose a serious risk to their health.

Specialty Enzymes & Biotechnologies’ Canadian product list
Company Product name NPN Lot(s) Usage Date Added
Kirkman Phenol Assist™ Unauthorized
  • 52640015
  • 53855003
  • 53855004
Digestive Aid December 23, 2013
Kirkman Biofilm Defense® Unauthorized
  • 53666006
  • 53666007
  • 53666008
  • 53666009
  December 23, 2013
Kirkman Enzym-Complete/DPP-IV™ Unauthorized
  • 52587047
  • 52587048
  • 52587049
  • 52587050
  • 52588047
  • 52588048
  • 52588049
  • 52588050
  • 52588051
  • 53853006
  • 53853007
  • 53853008
  • 53853009
  • 53853010
  • 53853011
  • 54956000
Digestive Aid December 23, 2013
Kirkman EnZym-Complete/DPP-IV™ II with Isogest® Unauthorized
  • 52939039
  • 52939040
  • 52939042
  • 52939043
  • 53852011
  • 53852012
  • 53852013
  • 53852015
  • 53852016
Digestive Aid December 23, 2013
Kirkman Maximum Spectrum Enzym-Complete/DPP-IV™ Fruit Free with Isogest® Unauthorized
  • 53854008
  • 53854010
  • 53854012
  • 53854013
  • 53854014
Digestive Aid December 23, 2013
Kirkman Chewable EnZym-Complete/DPP-IV™ with Isogest® Unauthorized
  • 54112001
Digestive Aid December 23, 2013
Kirkman Chewable Maximum Spectrum EnZym-Complete/DPP-IV™ with Isogest® Unauthorized
  • 54255000
Digestive Aid December 23, 2013
General Nutrition Centres Company (GNC) Women’s Phytoestrogen Formula 80036006
  • L2757653
Relief of menopausal symptoms December 17, 2013
Tall Grass Distribution Mega Foods High Active Enzymes N/A
  • 10804
  • 10971
  • 11510
  • 11968
  • 12752
  • 12753
  • 12794
  • 12795
  • 13344
  • 14072
  • 15729
  • 15947
  • 16025
Digestive aid November 21, 2013
Tall Grass Distribution Mega Foods Gluten & Dairy MegaZymes (30 tablets) N/A
  • 10554
  • 11908
  • 11909
  • 11972
  • 12362
  • 12613
  • 12798
  • 14239

Digestive aid

November 21, 2013
Tall Grass Distribution Mega Foods Gluten & Dairy MegaZymes (60 tablets) N/A
  • 10543
  • 11910
  • 11973
  • 12144
  • 12799
  • 14242
Digestive aid November 21, 2013
Tall Grass Distribution Mega Foods Vegan-Ease Digestive Enzymes 80035934
  • 10910
  • 10911
  • 11114
  • 12010
  • 12347
  • 12348
  • 12385
  • 12386
  • 12387
  • 12388
  • 12389
  • 14149
  • 14304
Digestive aid November 21, 2013
Sequel Naturals Ltd. Various products Various NHPs Various lots Digestive aid November 6, 2013
Valeant Canada Consumer Products Digestive Enzymes 500mg Capsules 80033138
  • 53611
  • 54104
  • 52612
  • 53907
  • 52177
  • 52482
Digestive aid October 21, 2013
Natural Factors Nutritional Products Limited Multi Enzyme capsules 02245142
  • 694274
  • 694275
Digestive aid October 19, 2013
Natural Factors Nutritional Products Limited Complete Megazymes tablets 00506508
  • 697740
  • 697441
Digestive aid October 19, 2013
WN Pharmaceuticals® Ltd Complete digestive Enzymes capsules 02248630
  • 693328
  • 695468
Digestive aid October 19, 2013
WN Pharmaceuticals® Ltd Complete digestive Enzymes capsules - blister pack 02248630
  • 695419
  • 696694
Digestive aid October 19, 2013
WN Pharmaceuticals® Ltd Digestive Enzymes tablets 02240677
  • 697742
Digestive aid October 19, 2013
Renew Life Canada Inc. GasStop 80036717
  • 2474900
Digestive aid October 19, 2013
Renew Life Canada Inc. DigestMORE HCl;
Advanced Naturals DigestMAX HCl
80037271
  • 2450600
  • 2474300
  • 2625000
Digestive aid October 19, 2013
Renew Life Canada Inc. DigestMORE;
Advanced Naturals DigestMAX
80005847
  • 2554800
  • 2554900
  • 2580100
Digestive aid October 19, 2013
Renew Life Canada Inc. CandiZYME 80036437
  • 2526300
Digestive aid October 19, 2013
Renew Life Canada Inc. DigestMORE ULTRA 80037290
  • 2474600
  • 2498300
  • 2504500
  • 2494800
Digestive aid October 19, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M2+ 02240497
  • 13225A
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M3+ 02240501
  • 13216A
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M4+ 02240561
  • 13255
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M5+ 02240572
  • 13087E
  • 13087F
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M6 02239966
  • 13241A
  • 13241B
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
NaturPham M7+ Capsules 02240571
  • 13086A
  • 13086B
  • 13256A
  • 13256B
Digestive aid October 18, 2013
Future Formulations Inc. Future Formulations Digestion Formula Forte 02240559
  • 13087A
  • 13087B
  • 13087C
  • 13087D
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
Future Formulations  Digestion Formula C 02240495
  • 13225B
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
Future Formulations  Digestion Formula F 02240496
  • 13216B
Digestive aid October 18, 2013
Future Formulations Inc.
1-800-465-2873 x223
Future Formulations  Tumi-Ease 02239965
  • 13241C
  • 13241D
Digestive aid October 18, 2013
Accurex Health Care Manufacturing Inc.
519-752-4937
Health First - PrimeZyme Plus Betaine 80039724
  • GO1364401
Digestive aid October 18, 2013
Gourmet Nutrition
1-800-363-7574
Kamizym-U 80036136
  • 131151KMU
  • 131261KMU
Digestive aid October 17, 2013
Gourmet Nutrition
1-800-363-7574
Kamizym+ 80033802
  • 131301KPL
Digestive aid October 17, 2013
Metagenics Canada
1-800-268-6200
Spectrazyme 80044751
  • 0413083
Digestive aid October 11, 2013
Adeeva Nutritionals
1-888-251-1010 (ext. 1014)
Flora Essentials 80039819
  • 10349
Digestive aid October 10, 2013

 

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