Health product recall

Mephyton (Phytonadione) 5mg Tablets(2021-05-26)

Starting date:
May 26, 2021
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-75747

Last updated:
2021-06-05

Summary

  • Product:
    Mephyton (Phytonadione) 5 mg Tablets

Reason

2-methyl-3 - ((E) -3,7,11,15-tetramethyl-hexadec-2-enyl) - [1,4] naphthoquinone impurity is out of specification in lot 19D012P.  2-methyl-3 - ((E) -3,7,11,15-tetramethyl-hexadec-2-enyl) - [1,4] naphthoquinone impurity is out of specification in lot 20D096P.

Depth of distribution

Healthcare Establishments

Affected products

Mephyton (Phytonadione) 5 mg Tablet

DIN, NPN, DIN-HIM

DIN N/A

Dosage form

Tablet

Strength

Phytonadione 5mg

Lot or serial number

19D012P, 20D096P

Companies

Recalling Firm

Bausch Health Canada Inc

2150 Boulevard St-Elzéar

Laval

H7L 4A8

Quebec

CANADA

Marketing Authorization Holder

N/A