Health product recall

Acid Reducer (Ranitidine) Tablet: N-nitrosodimethylamine (NDMA) impurity

Last updated

Summary

Product
Acid Reducer (Ranitidine) 75 mg Tablet; Maximum Strength Acid reducer (Ranitidine) 150 mg Tablet without prescription
Issue
Health products - Contamination
What to do

See instructions below. 

Affected products

Brand / Marque Product Name / Nom du produit Market Authorization / Autorisation de mise en marché Dosage Form / Forme posologique Strength / Concentration Lot number / Numéro de lot
Atoma ATOMA-ACID RED MAX F 150mg C ALV 3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765H
Option+ OPTION+ REDUC ACIDE 75mg COMP ALV 1x10 DIN 02247551 Tablet / Comprimé Ranitidine 75 mg 632952B
Option+ OPTION+ REDUC ACIDE 75mg COMP ALV 4X10 DIN 02247551 Tablet / Comprimé Ranitidine 75 mg 633694B
Option+ Option+ REDUC ACID F MAX 150mg CO ALV3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765G
Option+ Option+ REDUC ACID F MAX 150mg CO AL 1X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765B
Rexall Corp Rexall Corp-REDUC ACIDE 150mg CO ALV 3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765F
Rexall Corp Rexall Corp-REDUC ACIDE 150mg CO ALV 1X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765A
Biomedic BIOMEDIC REDUC ACIDE 75mg COMP ALV 3X10 DIN 02247551 Tablet / Comprimé Ranitidine 75 mg 632952I
Biomedic BIOMEDIC-ACID RED F MAX 150mg COM ALV3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765I
Biomedic BIOMEDIC-ACID RED F MAX 150mg COM ALV3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 628471C
LD LD-REDUC ACIDE F MAX 150mg COMP ALV 3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765E
Pharmasave PHARMASAVE-RED ACID F MAX 150mg CO AL1X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765C
Pharmasave PHARMASAVE-RED ACID F MAX 150mg C ALV3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 628471B
Co-op Care + CO-OP CARE + ACID REDU F M 150mg C AL3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 627765D
Compliments Compliments-REDUC ACIDE 150mg C ALV 3X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 628471D
Health One Health One-REDUC ACIDE 150mg COM ALV 4X8 DIN 02293471 Tablet / Comprimé Ranitidine 150 mg 628471A
Personnelle Personnelle-REDUC ACIDE 75mg CO ALV1X10 DIN 02247551 Tablet / Comprimé Ranitidine 75 mg 632952D
LB LB-REDUC D'ACIDE 75mg COMP ALV 3X10 DIN 02247551 Tablet / Comprimé Ranitidine 75 mg 632952K

Issue

Presence of N-nitrosodimethylamine (NDMA) above the acceptable concentration limit in affected lots.

What you should do

  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. Report any other health product safety complaints to Health Canada.

Additional information

Background

Depth of recall: Retailers

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Pharmasience Inc.

Suite 100, 6111, Royalmount Avenue,

Montreal, Quebec

H4P 2T4

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-63679

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