Health product recall

APO-Entecavir (2020-06-09)

Starting date:
June 9, 2020
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-73329

Last updated: 2020-06-11

Summary

  • Product: APO-Entecavir 0.5 mg Tablet

Reason

The unidentified impurity is out of specification in the affected lot.

Depth of distribution

Wholesalers, Retailers

Affected products

APO-Entecavir 0.5 mg Tablet

DIN, NPN, DIN-HIM

DIN 02396955

Dosage form

Tablet

Strength

Entecavir 0.5 mg

Lot or serial number

PY5990, PY5992

Companies

Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA