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Future Solution LX Universal Defense & bareMinerals Broad Spectrum SPF 50 (2017-12-15)
- Starting date:
- December 15, 2017
- Posting date:
- December 15, 2017
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs, Natural health products
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-66020
Affected Products
A. Future Solution LX Universal Defense
B. bareMinerals Broad Spectrum SPF 50 Daily Prep. Lotion
Reason
Affected lots were manufactured with an active pharmaceutical ingredient (zinc oxide) from a facility that did not comply with Good Manufacturing Practices (GMP).
Depth of distribution
Retailers
Affected products
A. Future Solution LX Universal Defense
DIN, NPN, DIN-HIM
DIN 02436248
Dosage form
Cream
Strength
OCTINOXATE 4.9 % w/w
OCTOCRYLENE 3 % w/w
OXYBENZONE 1 % w/w
ZINC OXIDE 15.4 % w/w
Lot or serial number
Lot# 6337ZG
Lot# 6109DG
Lot# 6180EG
Lot# 6015DG
Lot# 5154BG
Lot# 6053DG
Lot# 5303DG
Lot# 5229DG
Companies
- Recalling Firm
-
Shiseido Canada Inc.
303 Allstate Parkway
Markham
L3R 5P9
Ontario
CANADA
- Marketing Authorization Holder
-
SHISEIDO AMERICAS CORPORATION DIST
900 Third Avenue
New York
10022
B. bareMinerals Broad Spectrum SPF 50 Daily Prep. Lotion
DIN, NPN, DIN-HIM
NPN 80063006
Dosage form
Lotion
Strength
Titanium Dioxide 4.1%
Zinc Oxide 23.8%
Lot or serial number
Lot 067PHA1
Lot 111PHA1
Lot 116PHB1
Lot 117PHA1
Lot 064PHA1
Lot 064PHB1
Companies
- Recalling Firm
-
Shiseido Canada Inc.
303 Allstate Parkway
Markham
L3R 5P9
Ontario
CANADA
- Marketing Authorization Holder
-
SHISEIDO AMERICAS CORPORATION DIST
900 Third Avenue
New York
10022