Apotex Inc 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-71079

Last updated:

A. Selection Acid Reducer

B. Equate Acid Reducer

C. APO-Ranitidine Tablet 150mg

D. APO-Ranitidine Tablet 300mg

E. APO-Ranitidine

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. Selection Acid Reducer

DIN, NPN, DIN-HIM

DIN 02296160

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

B. Equate Acid Reducer

DIN, NPN, DIN-HIM

DIN 02296160

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

C. APO-Ranitidine Tablet 150mg

DIN, NPN, DIN-HIM

DIN 00733059

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

D. APO-Ranitidine Tablet 300mg

DIN, NPN, DIN-HIM

DIN 00733067

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300mg

Lot or serial number

All lots

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA

E. APO-Ranitidine

DIN, NPN, DIN-HIM

DIN 02280833

Dosage form

Solution

Strength

APO-Ranitidine Solution 75mg/5ml

Lot or serial number

All lots

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA