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Health product recall

Paclitaxel for Injection

Starting date:: May 31, 2013
Posting date:: June 19, 2013
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-34251

Reason
Depth of distribution
Affected products

Recalled products

Paclitaxel for Injection

Reason

Recall due to inadvertent re-release of lots involved in the investigation of customer complaints received outside of Canada for visual vial defects which resemble a rust-like mark at the neck of the vial or black particles close to the neck of the vial.

Depth of distribution

Wholesalers, hospitals and pharmacies in Canada.

Affected products

A. Paclitaxel for Injection

DIN, NPN, DIN-HIM

DIN 02296624

Dosage form

Solution

Strength

300 mg / 50 mL ( 6 mg/mL)

Lot or serial number

Y046843AB
Y056843AF
Y076847AB

Companies

Recalling Firm

Hospira Healthcare Corporation

600 - 1111 Dr. Frederik-Philips Blvd.

Saint-Laurent

H4M 2X6

Quebec

CANADA

Marketing Authorization Holder