This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Archived

This page has been archived on the Web.

Health product recall

Renew Life Canada - Recall (2013-10-20)

Starting date:
October 20, 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-36717

Recalled Products

  1. DigestMORE HCl
  2. Advanced Naturals DigestMAX HCl
  3. DigestMORE ULTRA
  4. DigestMORE
  5. Advanced Naturals DigestMAX
  6. GasSTOP

Reason

The product may contain the drug ingredient chloramphenicol.

Depth of distribution

National retail distribution.

Affected products

A. DigestMORE HCl

DIN, NPN, DIN-HIM
NPN 80037271
Dosage form

Capsules

Strength
  • (1-4)-alpha-D-galacturonan glycanohydrolase  10.0 mg 150.0 Endo-PG
  • 1-Carboxy-N,N,N-trimethylmethanaminium chloride  200.0 mg
  • 4-(1,3;1,4)-beta-D-Glucan 4-glucanohydrolase  1.7 mg 250.0 FCC CU
  • 4-alpha-D-Glucan glucanohydrolase  90.0 mg 9000.0 FCC DU
  • Beta-D-galactoside galactohydrolase  2.5 mg 250.0 FCC ALU
  • Malt diastase  12.5 mg 125.0 FCC DP
  • Protease  40.0 mg 20000.0 FCC HUT
  • Triacylglycerol lipase  11.25 mg 900.0 FCC LU
  • beta-D-fructofuranoside fructohydrolase  0.5 mg 50.0 FCC SU
  • myo-Inositol-hexakisphosphate 3-phosphohydrolase  1.0 mg  2.0 FCC FTU
Lot or serial number
  • 2450600
  • 2474300
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

B. Advanced Naturals DigestMAX HCl

DIN, NPN, DIN-HIM
NPN 80037271
Dosage form

Capsules

Strength
  • (1-4)-alpha-D-galacturonan glycanohydrolase  10.0 mg 150.0 Endo-PG
  • 1-Carboxy-N,N,N-trimethylmethanaminium chloride  200.0 mg
  • 4-(1,3;1,4)-beta-D-Glucan 4-glucanohydrolase  1.7 mg 250.0 FCC CU
  • 4-alpha-D-Glucan glucanohydrolase  90.0 mg 9000.0 FCC DU
  • Beta-D-galactoside galactohydrolase  2.5 mg 250.0 FCC ALU
  • Malt diastase  12.5 mg 125.0 FCC DP
  • Protease  40.0 mg 20000.0 FCC HUT
  • Triacylglycerol lipase  11.25 mg 900.0 FCC LU
  • beta-D-fructofuranoside fructohydrolase  0.5 mg 50.0 FCC SU
  • myo-Inositol-hexakisphosphate 3-phosphohydrolase  1.0 mg  2.0 FCC FTU
Lot or serial number
  • 2625000
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

C. DigestMORE ULTRA

DIN, NPN, DIN-HIM
NPN 80037290
Dosage form

Capsules

Strength
  • 1,3-(1-3,1-4)-beta-D-glucan 3(4)-glucanohydrolase  25,0 FCC BGU 25,0 mg
  • 1,3-beta-D-xylan xylanohydrolase  0,1 mg 30,0 FCC HCU
  • 1,3-beta-D-xylan xylanohydrolase  22,0 mg 550,0 FCC XU
  • 1,4-alpha-D-Glucan glucohydrolase  50,0 FCC AGU 50,0 mg
  • 4-(1,3;1,4)-beta-D-Glucan 4-glucanohydrolase  10,0 mg 1500,0 FCC CU
  • 4-alpha-D-Glucan glucanohydrolase  250,0 mg 25000,0 FCC DU
  • Beta-galactosidase  12,0 mg 1200,0 FCC ALU
  • Papain  1,1 mg 50000,0 FCC PU
  • Pectin pectylhydrolase  3,0 mg 45,0 Endo-PG
  • Protease  200,0 mg 100000,0 FCC HUT
  • Triacylglycerol lipase  25.0 mg 18750.0 FCC LU
  • alpha-D-Galactoside galactohydrolase  50.0 mg 500.0 FCC GalU
  • beta-D-fructofuranoside fructohydrolase  2.5 mg 50.0 FCC SU
  • orthophosphoric-mono ester phosphohydrolase  2.5 mg  5.0 FCC FTU
Lot or serial number
  • 2504500
  • 2474600
  • 2498300
  • 2494800
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

D. DigestMORE

DIN, NPN, DIN-HIM
NPN 80005847
Dosage form

Capsules

Strength
  • Althaea officinalis  25.0 mg
  • Amylase  90.0 mg
  • Bromelain  10.0 mg
  • Carica papaya  25.0 mg
  • Cellulase  1.7 mg
  • Invertase  0.5 mg
  • L-Glutamine  100.0 mg
  • Lactase  2.5 mg
  • Lipase  11.2 mg
  • Malt diastase  12.5 mg
  • N-acetyl-D-glucosamine  10.0 mg
  • Pectinase  10.0 mg
  • Phytase  1.0 mg
  • Protease  40.0 mg
  • Zingiber officinale  25.0 mg
  • gamma-Oryzanol  10.0 mg
Lot or serial number
  • 2554800
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

E. Advanced Naturals DigestMAX

DIN, NPN, DIN-HIM
NPN 80005847
Dosage form

Capsules

Strength
  • Althaea officinalis  25.0 mg
  • Amylase  90.0 mg
  • Bromelain  10.0 mg
  • Carica papaya  25.0 mg
  • Cellulase  1.7 mg
  • Invertase  0.5 mg
  • L-Glutamine  100.0 mg
  • Lactase  2.5 mg
  • Lipase  11.2 mg
  • Malt diastase  12.5 mg
  • N-acetyl-D-glucosamine  10.0 mg
  • Pectinase  10.0 mg
  • Phytase  1.0 mg
  • Protease  40.0 mg
  • Zingiber officinale  25.0 mg
  • gamma-Oryzanol  10.0 mg
Lot or serial number
  • 2580100
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

F. GasSTOP

DIN, NPN, DIN-HIM
NPN 80036717
Dosage form

Capsules

Strength
  • 4-(1,3;1,4)-beta-D-Glucan 4-glucanohydrolase  10.0 mg 1500.0 FCC CU
  • 4-alpha-D-Glucan glucanohydrolase  100.0 mg 10000.0 FCC DU
  • Foeniculum vulgare subsp. vulgare var. dulce  175.0 mg
  • Protease  10.0 mg 5000.0 FCC HUT
  • Triacylglycerol lipase  6.25 mg 600.0 FCC LU
  • alpha-D-Galactoside galactohydrolase  50.0 mg 500.0 FCC AGU
  • beta-D-fructofuranoside fructohydrolase  2.5 mg 250.0 FCC SU
  • myo-Inositol-hexakisphosphate 3-phosphohydrolase  10.0 mg 20.0 FCC PU
Lot or serial number
  • 2474900
Companies
Recalling Firm
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA
Marketing Authorization Holder
Renew Life Canada
8-1273 North Service Road
Oakville
L6H 1A7
Ontario
CANADA

Date modified: