The Recall Desk

FDA (Drugs) recall action 73574

Sesderma, SL recalled 10 products on 2016-05-18

The FDA (Drugs) publishes a recall like this one as 10 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 10 pages.

Products
10
Announced
2016-05-18
Critical
0
Units
1,767

Why these products were recalled

cGMP Deviations; product does not comply with cGMP 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.

States named across these recalls

1–10 of 10

  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations

    Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Salises Acne Gel Recalled for cGMP Deviations

    Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.

    Product
    Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Sunscreen Recalled for cGMP Non-Compliance

    Sesderma is recalling 44 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations

    Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

    Product
    Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 20 bottles of Repaskin 30 sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling Dryses Aluminum Chlorohydrate Deodorant for Men because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen for cGMP Deviations

    Sesderma is recalling 66 bottles of Repaskin 50 sunscreen due to cGMP deviations. The product was distributed to Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2016-05-18

    Sesderma Sunscreen Recalled for cGMP Deviations

    Sesderma is recalling 45 compacts of Screenses Color Sunscreen due to cGMP deviations. The product is distributed in Florida, Puerto Rico, Colorado, and Georgia.

    Product
    Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
    Category
    Distribution
    4 states