Health product recall

Medisca Gentian Violet Product Recall (2019-08-01)

Starting date:
August 1, 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-70681



Last updated: 2019-08-13

Summary

  • Product:
    • A. Gentian Violet Topical Solution USP 1%;
    • B. Gentian Violet Topical Solution USP 1% aq;
    • C. Gentian Violet USP crystals;
    • D. Bonney's Blue solution
  • A. Gentian Violet Topical Solution USP 1%;
  • B. Gentian Violet Topical Solution USP 1% aq;
  • C. Gentian Violet USP crystals;
  • D. Bonney's Blue solution

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 Topical Solution USP 1%;

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Solution

Strength

Gentian violet 1%

Lot or serial number

MM423/A, MM423/B, MM424/A, MM424/B, MM424/C, MM424/D, MM424/E, MM424/F, MM445/A, MM446/B, MM446/C, MM446/D, MM446/E, MM459/A, MM459/B, MM459/C, MM460/A, MM460/B, MM460/C, MM494/A, MM494/B, MM494/C, MM495/A, MM495/B, MM496/A, MM496/B, MM496/C, MM503/A, MM503/B, MM503/C, MM504/A, MM504/B, MM505/A, MM505/B, MM505/C, MM506/A, MM506/B, MM506/C, MM506/D, MM506/E, 610503/A, 610503/B, 610504/A, 610504/B, 610504/C, 612507/A, 612507/B, 612508/A, 612508/B, 615624/B, 615624/C, 615625/A, 615625/B, 617081/A, 617081/B, 617082/A, 617082/B, 624766/A, 624766/B, 624766/C

Companies

Recalling Firm

Medisca

4509 Dobrin

Saint-Laurent

H4R 2L8

Quebec

CANADA

Marketing Authorization Holder

N/A


B. Gentian Violet Topical Solution USP 1% aq

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Solution

Strength

Gentian violet 1%

Lot or serial number

MM451/A, MM452/A, MM453/A, MM493/A, 610502/A, 612509/A, 614464/A, 616148/A, 624767/A

Companies

Recalling Firm

Medisca

4509 Dobrin

Saint-Laurent

H4R 2L8

Quebec

CANADA

Marketing Authorization Holder

N/A


C. Gentian Violet USP crystals

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Crystals

Strength

Gentian Violet USP crystals 100%

Lot or serial number

627029/A

Companies

Recalling Firm

Medisca

4509 Dobrin

Saint-Laurent

H4R 2L8

Quebec

CANADA

Marketing Authorization Holder

N/A


D. Bonney's Blue solution

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Solution

Strength

Ethanol 48%

Gentian violet

Lot or serial number

617217/A, 617217/B, 617217/C

Companies

Recalling Firm

Medisca

4509 Dobrin

Saint-Laurent

H4R 2L8

Quebec

CANADA

Marketing Authorization Holder

N/A