Sun Pharma Canada Inc. Ranitidine Product Recall (2019-10-29)

Starting date:
October 29, 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-71495

Last updated:

A. RAN-Ranitidine 150mg

B. RAN-Ranitidine 300mg

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. RAN-Ranitidine 150mg

DIN, NPN, DIN-HIM

DIN 02336480

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

7703396A, 7703396B

Companies

Recalling Firm
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
Marketing Authorization Holder
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA

B. RAN-Ranitidine 300mg

DIN, NPN, DIN-HIM

DIN 02336502

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300mg

Lot or serial number

7703365A, 7702668A

Companies

Recalling Firm
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA
Marketing Authorization Holder
Sun Pharma Canada Inc.
126 East Drive
Brampton
L6T 1C1
Ontario
CANADA