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:

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