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