Health product recall

Sivem Pharmaceuticals ULC Ranitidine Product Recall (2019-10-17)

Starting date:
October 17, 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-71357

Last updated: 2019-10-21

Summary

  • Product:
    A.  Ranitidine 300 mg Tablet;

    B.  Ranitidine 150 mg Tablet

A.  Ranitidine 300 mg Tablet;  

B.  Ranitidine 150 mg Tablet

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 300 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385961

Dosage form

Tablet

Strength

Ranitidine 300 mg

Lot or serial number

K50941, K50624, K50947, K50950

Companies

Recalling Firm

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent

H4R 2P7

Quebec

CANADA

Marketing Authorization Holder

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent

H4R 2P7

Quebec

CANADA

B.  Ranitidine 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02385953

Dosage form

Tablet

Strength

Ranitidine 150 mg

Lot or serial number

K46484, K50204, K46485, K50206, K50590, K50677, K50908, K48440, K48679, K50207, K50594, K50925, K50928, K50932, K50935, K51080

Companies

Recalling Firm

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent

H4R 2P7

Quebec

CANADA

Marketing Authorization Holder

Sivem Pharmaceuticals ULC

4705 Dobrin Street

Saint-Laurent

H4R 2P7

Quebec

CANADA