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Health product recall

ZO Skin Health Hydroquinone product recall (2019-08-15)

Starting date:
August 15, 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-70763

Last updated: 2019-08-19

A. Melamix TM; Melamin TM Cream;

B. Melamin-C Skin Bleaching & Correcting Cream With 20% Vitamin C;

C. Zo Multi-Therapy Hydroquinone System Cream;

D. Melamix TM; Melamin TM Cream;

E. Melamin-C Skin Bleaching & Correcting Cream With 20% Vitamin C;

F. Zo Multi-Therapy Hydroquinone System Cream

Reason

As of June 30, 2019, products containing hydroquinone greater than 2% will require a prescription from a healthcare practitioner to be sold in Canada and valid market authorization.

Depth of distribution

Retailers

Affected products

A. Melamix TM; Melamin TM Cream

DIN, NPN, DIN-HIM

NPN 80038901

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

8191A, 8151F, 8093B, 7051C, 6280A, 8176A, 8157A, 8066A, 7158C, 7041A

Companies

Recalling Firm

Mirza Alladina Medical Ltd.

#312-1952 Kingsway Avenue

Port Coquitlam

V3C 6C2

British Columbia

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES

B. Melamin-C Skin Bleaching & Correcting Cream With 20% Vitamin C

DIN, NPN, DIN-HIM

NPN 80072697

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

8129A

Companies

Recalling Firm

Mirza Alladina Medical Ltd.

#312-1952 Kingsway Avenue

Port Coquitlam

V3C 6C2

British Columbia

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES

C. Zo Multi-Therapy Hydroquinone System Cream

DIN, NPN, DIN-HIM

NPN 80064165

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

709

Companies

Recalling Firm

Mirza Alladina Medical Ltd.

#312-1952 Kingsway Avenue

Port Coquitlam

V3C 6C2

British Columbia

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES

D. Melamix TM; Melamin TM Cream

DIN, NPN, DIN-HIM

NPN 80038901

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

8191A, 8151F, 8093B, 7051C, 6280A, 8176A, 8157A, 8066A, 7158C, 7041A

Companies

Recalling Firm

SCM Products Inc.

5420 North Service Rd, Ste 105

Burlington

L7L 6C7

Ontario

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES

E. Melamin-C Skin Bleaching & Correcting Cream With 20% Vitamin C

DIN, NPN, DIN-HIM

NPN 80072697

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

8129A

Companies

Recalling Firm

SCM Products Inc.

5420 North Service Rd, Ste 105

Burlington

L7L 6C7

Ontario

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES

F. Zo Multi-Therapy Hydroquinone System Cream

DIN, NPN, DIN-HIM

NPN 80064165

Dosage form

Cream

Strength

Hydroquinone 4.0 % (w/w)

Lot or serial number

709

Companies

Recalling Firm

SCM Products Inc.

5420 North Service Rd, Ste 105

Burlington

L7L 6C7

Ontario

CANADA

Marketing Authorization Holder

ZO Skin Health Inc.

9685 Research Dr.

Irvine

92618

California

UNITED STATES