Health product recall

Teva Canada 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-71339



Last updated: 2019-10-18

Summary

  • Product:
    A.  ACT-Ranitidine 150 mg Tablet;   

    B.  ACT-Ranitidine 300 mg Tablet

A.  ACT-Ranitidine 150 mg Tablet;  

B.  ACT-Ranitidine 300 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.  ACT-Ranitidine 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02248570

Dosage form

Tablet

Strength

Ranitidine 150 mg

Lot or serial number

K51136, K58444, K50205, K50860, K51114, K51139, K51141, K52964, K58446, K46486, K50593, K51071, K51076, K51144, K51146, K51148, K51150, K51152, K51154, K51164, K52965, K52966, K55591, K50203, K51069, K51132

Companies

Recalling Firm

Teva Canada Limited

30 Novopharm Court

Toronto

M1B 2K9

Ontario

CANADA

Marketing Authorization Holder

Teva Canada Limited

30 Novopharm Court

Toronto

M1B 2K9

Ontario

CANADA


B.  ACT-Ranitidine 300 mg Tablet

DIN, NPN, DIN-HIM

DIN 02248571

Dosage form

Tablet

Strength

Ranitidine 300 mg

Lot or serial number

K50175, K50944, K51170, K51171, K51172, K51173

Companies

Recalling Firm

Teva Canada Limited

30 Novopharm Court

Toronto

M1B 2K9

Ontario

CANADA

Marketing Authorization Holder

Teva Canada Limited

30 Novopharm Court

Toronto

M1B 2K9

Ontario

CANADA