Pro Doc Limitee 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-71063

Last updated:

A. Ranitidine- 150

B. Ranitidine- 300

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- 150

DIN, NPN, DIN-HIM

DIN 00740748

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150 mg

Lot or serial number

All lots

Companies

Recalling Firm
Pro Doc Limitee
2925 Boulevard Industriel
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Limitee
2925 Boulevard Industriel
Laval
H7L 3W9
Quebec
CANADA

B. Ranitidine- 300

DIN, NPN, DIN-HIM

DIN 00740756

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300 mg

Lot or serial number

All lots

Companies

Recalling Firm
Pro Doc Limitee
2925 Boulevard Industriel
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Limitee
2925 Boulevard Industriel
Laval
H7L 3W9
Quebec
CANADA