Health product recall

TOBRAMYCIN INJECTION USP 40mg/ml(2021-06-21)

Starting date:
June 21, 2021
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-75897

Last updated: 2021-06-24

Summary

  • Product: TOBRAMYCIN INJECTION USP 40mg/ml

Reason

The assay results for antioxidant, sodium metabisulfite, is out of specification in the affected lot.

Depth of distribution

Retailers, Wholesalers

Affected products

TOBRAMYCIN INJECTION USP 40mg/ml

DIN, NPN, DIN-HIM

DIN 02502372

Dosage form

Solution

Strength

TOBRAMYCIN (TOBRAMYCIN SULFATE) 40 MG / ML

Lot or serial number

AEP002

Companies

Recalling Firm
Sterimax Inc.
2770 Portland Drive
Oakville
L6H 6R4
Ontario
CANADA
Marketing Authorization Holder
Sterimax Inc.
2770 Portland Drive
Oakville
L6H 6R4
Ontario
CANADA

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