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:

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