Pharmascience Inc. Ranitidine Product Recall (2019-10-23)

Starting date:
October 23, 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-71419

Last updated:
  1. Acid Reducer 75mg
  2. Acid Reducer 150mg
  3. Maximum Strength Acid Reducer Without Prescription 150mg
  4. PMS-Ranitidine 150mg
  5. PMS-Ranitidine 300mg

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. Acid Reducer 75mg

DIN, NPN, DIN-HIM

DIN 02247551

Dosage form

Tablet

Strength

Ranitidine hydrochloride 75mg

Lot or serial number

All lots

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA

B. Acid Reducer 150mg

DIN, NPN, DIN-HIM

DIN 02400103

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA

C. Maximum Strength Acid Reducer Without Prescription 150mg

DIN, NPN, DIN-HIM

DIN 02293471

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA

D. PMS-Ranitidine 150mg

DIN, NPN, DIN-HIM

DIN 02242453

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150mg

Lot or serial number

All lots

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA

E. PMS-Ranitidine 300mg

DIN, NPN, DIN-HIM

DIN 02242454

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300mg

Lot or serial number

All lots

Companies

Recalling Firm
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
Marketing Authorization Holder
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA