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Health product recall

Future Formulations Inc. - Recall (2013-10-18)

Starting date:
October 18, 2013
Posting date:
November 21, 2013
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36745

Recalled Products

  1. NaturPham M2 +
  2. NaturPham M3+
  3. NaturPham M4+
  4. NaturPham  M5+
  5. NaturPham M6+
  6. NaturPham M7+
  7. Digestion Formula Forte
  8. Digestion Formula C
  9. Digestion Formula F
  10. Tumi-Ease

Reason

The product may contain the drug ingredient chloramphenicol.

Depth of distribution

Retail level

Affected products

A. NaturPham M2 +

 

DIN, NPN, DIN-HIM

NPN 02240497

Dosage form

Capsules

Strength
  • Alpha-Amylase 36666.7 DU
  • Amylo-Glucosidase (Gluco-Amylase) 3.0 AG
  • Alpha-Galactosidase 33.3 GalU
  • Malt Diastase (Maltase) 146.7 DPO
  • Invertase (Sucrase) 42.0 INVU
  • Lactase (Beta-Galactosidase) 133.3 LacU
  • Lipase I 233.3 LU
  • Lipase II 22.2 LU
  • Cellulase I 40.0 CU
  • Cellulase II 200.0 CMC-ase
  • Hemi-Cellulase 33.3 HCU
  • Pectinase 10.0 PGU
  • Phytase 2.5 PU
Lot or serial number
  • 13225A
Companies
Recalling Firm

Total Health Centre

1060 Tapscott Road

Toronto

M1X 1E7

Ontario

CANADA

Marketing Authorization Holder

Future Formulations Inc.

1080 Tapscott Road

Toronto

M1X 1E7

Ontario

CANADA



B. NaturPham M3+

 

DIN, NPN, DIN-HIM

NPN 02240501

Dosage form

Capsules

Strength
  • Lipase I 2100.0 LU
  • Lipase II 201.0 LU
  • Alpha-Amylase 6111.1 DU
  • Amylo-Glucosidase (Gluco-Amylase) 0.5 AG
  • Alpha-Galactosidase 5.5 GalU
  • Malt Diastase (Maltase) 140.0 DPO
  • Invertase (Sucrase) 10.6 INVU
  • Lactase (Beta-Galactosidase) 133.3 LacU
  • Cellulase I 13.3 CU
  • Cellulase II 66.6 CMC-ase
  • Hemi-Cellulase 11.1 HCU
  • Pectinase 3.3PGU
  • Phytase 0.8 PU
    Lot or serial number
    • 13216A
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    C. NaturPham M4+

     

    DIN, NPN, DIN-HIM

    NPN 02240561

    Dosage form

    Capsules

    Strength
    • Protease I 14166.7 HUT
    • Protease II 1250.0 PC
    • Protease III 25.0 SAP
    • Protease IV 33333.3 PU
    • Protease V 38333.3 PU
    • Alpha-Amylase 9166.7 DU
    • Amylo-Glucosidase (Gluco-Amylase) 0.75 AG
    • Alpha-Galactosidase 8.3 GalU
    • Malt Diastase (Maltase) 36.7 DPO
    • Invertase (Sucrase) 5.3 INVU
    • Lactase (Beta-Galactosidase) 100.0 LacU
    • Lipase I 350.0 LU
    • Lipase II 33.0 LU
    • Cellulase I 20.0 CU
    • Cellulase II 100.0 CMC-ase
    • Hemi-Cellulase 16.7 HCU
    • Pectinase 5.0 PGU
    • Phytase 1.25 PU
    Lot or serial number
    • 13255
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    D. NaturPham  M5+

     

    DIN, NPN, DIN-HIM

    NPN 02240572

    Dosage form

    Capsules

    Strength
    • Protease I 8333.3 HUT
    • Protease II 2500.0 PC
    • Protease III 50.0 SAP
    • Protease IV 66666.7 PU
    • Protease V 76666.7PU
    • Alpha-Amylase 18333.3 DU
    • Amylo-Glucosidase (Gluco-Amylase) 1.5 AG
    • Alpha-Galactosidase 16.7 GalU
    • Malt Diastase (Maltase) 73.3 DPO
    • Invertase (Sucrase) 10.7 INVU
    • Lactase (Beta-Galactosidase) 200.0 LacU
    • Lipase I 700.0 LU
    • Lipase II 67.0 LU
    • Cellulase I 40.0 CU
    • Cellulase II 200.0 CMC-ase
    • Hemi-Cellulase 33.3 HCU
    • Pectinase 10.0 PGU
    • Phytase 2.5 PU
    Lot or serial number
    • 13087E (120 Capsules)
    • 13087F (60 Capsules)
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    E. NaturPham M6+

     

    DIN, NPN, DIN-HIM

    NPN 02239966

    Dosage form

    Capsules

    Strength
    • Alpha-Amylase/Gluco-Amylase 1375.0 USP
    • Total Lipase Activity 250.0 FCC Units
    • Total Cellulase Activity 20.0 FCC Units
    Lot or serial number
    • 13241A  (60 Capsules)
    • 13241B  (180 Capsules)
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    F. NaturPham M7+

     

    DIN, NPN, DIN-HIM

    NPN 02240571

    Dosage form

    Capsules

    Strength
    • Protease I 12500.0 HUT
    • Protease II 3750.0 PC
    • Protease III 75.0 SAP
    • Protease IV 100000.0 PU
    • Protease V 115000.0 PU
    • Alpha-Amylase 27500.0 DU
    • Amylo-Glucosidase (Gluco-Amylase) 2.25 AG
    • Alpha-Galactosidase 25.0 GalU
    • Malt Diastase (Maltase) 110.0 DPO
    • Invertase (Sucrase) 16.0 INVU
    • Lactase (Beta-Galactosidase) 300.0 LacU
    • Lipase I 1050.0 LU
    • Lipase II 100.0 LU
    • Cellulase I 60.0 CU
    • Cellulase II 300.0 CMC-ase
    • Hemi-Cellulase 50.0 HCU
    • Pectinase 15.0 PGU
    • Phytase 3.75 PU
    Lot or serial number
    • 13086A  (180 Capsules)
    • 13086B  (120 Capsules)
    • 13256A  (60 Capsules)
    • 13256B  (360 Capsules)
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    G. Digestion Formula Forte

     

    DIN, NPN, DIN-HIM

    NPN 02240559

    Dosage form

    Capsules

    Strength
    • Protease I 12500.0 HUT
    • Protease II 3750.0 PC
    • Protease III 75.0 SAP
    • Protease IV 100000.0 PU
    • Protease V 115000.0 PU
    • Alpha-Amylase 27500.0 DU
    • Amylo-Glucosidase (Gluco-Amylase) 2.25 AG
    • Alpha-Galactosidase 25.0 GalU
    • Malt Diastase (Maltase) 110.0 DPO
    • Invertase (Sucrase) 16.0 INVU
    • Lactase (Beta-Galactosidase) 300.0 LacU
    • Lipase I 1050.0 LU
    • Lipase II 100.0 LU
    • Cellulase I 60.0 CU
    • Cellulase II 300.0 CMC-ase
    • Hemi-Cellulase 50.0 HCU
    • Pectinase 15.0 PGU
    • Phytase 3.75 PU
    Lot or serial number
    • 13087A  (180 Capsules)
    • 13087B  (120 Capsules)
    • 13087C  (60 Capsules)
    • 13087D (360 Capsules)
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    H. Digestion Formula C

     

    DIN, NPN, DIN-HIM

    NPN 02240495

    Dosage form

    Capsules

    Strength
    • Alpha-Amylase 36666.0 LU
    • Amylo-Glucosidase (Gluco-Amylase) 33.0 LU
    • Alpha-Galactosidase 33.0 DU
    • Malt Diastase (Maltase) 146.0 DPO
    • Invertase (Sucrase) 42.0 INVU
    • Lactase (Beta-Galactosidase) 133.0 LacU
    • Lipase I 233.0 LacU
    • Lipase II 22.0 LacU
    • Cellulase I 40.0 CU
    • Cellulase II 200.0 CMC-ase
    • Hemi-Cellulase 33.0 HCU
    • Pectinase 10.0 PGU
    • Phytase 2.5 PU
    Lot or serial number
    • 13225B
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    I.  Digestion Formula F

    DIN, NPN, DIN-HIM

    NPN 02240496

    Dosage form

    Capsules

    Strength
    • Lipase I 2100.0 LU
    • Lipase II 201.0 LU
    • Alpha-Amylase 6111.1 DU
    • Amylo-Glucosidase (Gluco-Amylase) 0.5 AG
    • Alpha-Galactosidase 5.5 GalU
    • Malt Diastase (Maltase) 48.8 DPO
    • Invertase (Sucrase) 10.6 INVU
    • Lactase (Beta-Galactosidase) 133.3 LacU
    • Cellulase I 13.3 CU
    • Cellulase II 66.6 CMC-ase
    • Hemi-Cellulase 11.1 HCU
    • Pectinase 3.3PGU
    • Phytase 0.8 PU
    Lot or serial number
    • 13216B
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA



    J. Tumi-Ease

     

    DIN, NPN, DIN-HIM

    NPN 02239965

    Dosage form

    Capsules

    Strength
    • Lipase I 2100.0 LU
    • Lipase II 201.0 LU
    • Alpha-Amylase 6111.1 DU
    • Amylo-Glucosidase (Gluco-Amylase) 0.5 AG
    • Alpha-Galactosidase 5.5 GalU
    • Malt Diastase (Maltase) 48.8 DPO
    • Invertase (Sucrase) 10.6 INVU
    • Lactase (Beta-Galactosidase) 133.3 LacU
    • Cellulase I 13.3 CU
    • Cellulase II 66.6 CMC-ase
    • Hemi-Cellulase 11.1 HCU
    • Pectinase 3.3PGU
    • Phytase 0.8 PU
    Lot or serial number
    • 13241C (60 Capsules)
    • 13241D (180 Capsules)
    Companies
    Recalling Firm

    Total Health Centre

    1060 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA

    Marketing Authorization Holder

    Future Formulations Inc.

    1080 Tapscott Road

    Toronto

    M1X 1E7

    Ontario

    CANADA