Health product recall

Teva Canada Product Recall (2018-11-23)

Starting date:
November 23, 2018
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68408

Recalled Product

A. Novamoxin Granules for Oral Suspension 125mg/5mL

B. Novamoxin Granules for Oral Suspension 250mg/5mL

Reason

Out of specification results for homogeneity.

Depth of distribution

Retailers

Affected products

A. Novamoxin Granules for Oral Suspension 125mg/5mL

DIN, NPN, DIN-HIM
DIN 00452149
Dosage form

Granules for suspension

Strength

Amoxicillin 125mg/5mL

Lot or serial number

35438292B, 35438811A

Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA

B. Novamoxin Granules for Oral Suspension 250mg/5mL

DIN, NPN, DIN-HIM
DIN 00452130
Dosage form

Granules for suspension

Strength

Amoxicillin 250mg/5mL

Lot or serial number

35439807A

Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA