The Recall Desk

FDA (Drugs) recall action 80184

Shadow Holdings DBA Bocchi Labs recalled 4 products on 2018-06-20

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-06-20
Critical
0
Units
40,608

Why these products were recalled

CGMP Deviations: products may be contaminated with bacteria.

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.

1–4 of 4

  • SevereFDA (Drugs)··2018-06-20

    Acne Shave 3 Step Shaving System Recalled for Bacterial Contamination Risk

    Shadow Holdings DBA Bocchi Labs is recalling the Acne Shave 3 Step Shaving System due to CGMP deviations that may result in bacterial contamination.

    Product
    Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos C
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2018-06-20

    Bocchi Labs Recalls Acne Shave Post-Shave Moisturizer Due to Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Post-Shave Moisturizer because products may be contaminated with bacteria due to CGMP deviations.

    Product
    Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-06-20

    Acne Shave Shave Cream Recalled for Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.

    Product
    Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-06-20

    FDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination

    Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed bacterial contamination.

    Product
    X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
    Category
    Distribution
    0 states