Health product recall

APO-Entecavir (2020-04-15)

Starting date:
April 15, 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-72793

Last updated: 2020-04-16

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, Healthcare establishments

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

PY5989

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