Health product recall

Galenova Inc. Products Recall (2019-07-05)

Starting date:
July 5, 2019
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-70501

Last updated: 2019-07-22

Summary

  • Product:
    Gentian violet 1%

    Gentian violet 3%

    Gentian violet 0.5%

    Gentian violet USP

  1. Gentian violet 1% (API)
  2. Gentian violet 3% (API)
  3. Gentian violet 0.5% (API)
  4. Gentian violet USP (API)

Reason

The affected lot contains Gentian violet which may pose the risk to health.

Depth of distribution

Wholesalers, Retailers, Healthcare Establishments

Affected products

A. Gentian violet 1% (API)

DIN, NPN, DIN-HIM

N/A

Dosage form

Solution

Strength

Gentian violet 1%

Lot or serial number

15012, 15065, 15073, 15074, 15086, 15098, 15115, 15116, 15186, 15195, 15196, 15219, 15220, 15241, 15242, 15303, 15304, 15335, 15343, 15354, 15364, 15368, 15400, 15409, 15420, 15429, 15456, 15467, 15475, 15476, 15511, 15512, 15513, 15574, 15583, 15619, 15620, 15639, 15671, 15685, 15686, 15700, 15721, 15722

Companies

Recalling Firm

Galenova Inc.

4555 Beaudry avenue

Saint-Hyacinthe

J2S 8W2

Quebec

CANADA

Marketing Authorization Holder

N/A

B. Gentian violet 3% (API)

DIN, NPN, DIN-HIM

N/A

Dosage form

Solution

Strength

Gentian violet 3%

Lot or serial number

15386, 15481, 15704, 15784, 15869

Companies

Recalling Firm

Galenova Inc.

4555 Beaudry avenue

Saint-Hyacinthe

J2S 8W2

Quebec

CANADA

Marketing Authorization Holder

N/A

C. Gentian violet 0.5% (API)

DIN, NPN, DIN-HIM

N/A

Dosage form

Solution

Strength

Gentian violet 0.5%

Lot or serial number

15416

Companies

Recalling Firm

Galenova Inc.

4555 Beaudry avenue

Saint-Hyacinthe

J2S 8W2

Quebec

CANADA

Marketing Authorization Holder

N/A

D. Gentian violet USP (API)

DIN, NPN, DIN-HIM

N/A

Dosage form

Powder for solution

Strength

Gentian violet

Lot or serial number

14928-8088, 01697-8276, 01697-9128

Companies

Recalling Firm

Galenova Inc.

4555 Beaudry avenue

Saint-Hyacinthe

J2S 8W2

Quebec

CANADA

Marketing Authorization Holder

N/A