The Recall Desk

FDA (Drugs) recall action 78791

SHISEIDO AMERICA INC. recalled 5 products on 2018-01-24

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2018-01-24
Critical
0
Units
248,661

Why these products were recalled

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • ModerateFDA (Drugs)··2018-01-24

    Shiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations

    Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-24

    Shiseido Future Solutions LX Triple Points Bonus Recalled for GMP Deviations

    Shiseido America Inc. is recalling Shiseido Future Solutions LX Triple Points Bonus because the manufacturing of the active pharmaceutical ingredient did not meet GMP and quality requirements.

    Product
    Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-24

    Shiseido Eye and Lip Collection Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Luxurious Eye & Lip Collection because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-24

    Shiseido Sunscreen Recalled for Manufacturing Quality Deviations

    Shiseido America Inc. is recalling Future Solution LX Universal Defense SPF 50+ sunscreen because the manufacturing of active ingredient material did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-01-24

    Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Discovery Set because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
    Category
    Distribution
    0 states