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Health product recall

Ketorolac Tromethamine Injection USP (2015-12-24)

Starting date:
December 24, 2015
Posting date:
January 7, 2016
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56526

Affected Products

Ketorolac Tromethamine Injection USP

Reason

Crystals found in some vials during a routine inspection of retained samples.

Depth of distribution

Wholesalers and hospital pharmacies across Canada.

Affected products

Ketorolac Tromethamine Injection USP

DIN, NPN, DIN-HIM

DIN 02239944

Dosage form

Liquid

Strength

30mg/mL

Lot or serial number

EU2636

EU9316

EY6512

FG5329

FH0076

Companies
Recalling Firm

Sandoz Canada Inc.

145 Jules-Léger

Boucherville

J4B 7K8

Quebec

CANADA

Marketing Authorization Holder

Sandoz Canada Inc.

145 Jules-Léger

Boucherville

J4B 7K8

Quebec

CANADA