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Health product recall

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

Date modified: