Sanis Health Inc. Ranitidine Product Recall (2019-09-24)

Starting date:
September 24, 2019
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71081

Last updated:

A. Ranitidine

B. Ranitidine

Reason

Affected lots may be manufactured with an API containing an impurity, N-nitrosodimethylamine (NDMA).

Depth of distribution

Wholesalers, Healthcare Establishments, Retailers

Affected products

A. Ranitidine

DIN, NPN, DIN-HIM

DIN 02353016

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA

B. Ranitidine

DIN, NPN, DIN-HIM

DIN 02353024

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300mg

Lot or serial number

All lots

Companies

Recalling Firm
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
Marketing Authorization Holder
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA