The Recall Desk

FDA (Drugs) recall action 81556

CAO Group, Inc. recalled 4 products on 2018-12-19

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
2018-12-19
Critical
0
Units
788

Why these products were recalled

cGMP violations noted during the firm's most recent inspection.

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

  • ModerateFDA (Drugs)··2018-12-19

    CAO Group Recalls fas.TRACT Hemostatic Gel Due to cGMP Violations

    CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.

    Product
    fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-12-19

    CAO Group Recalls FastStat Topical Hemostat Kits Due to cGMP Violations

    CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.

    Product
    FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-12-19

    CAO Group Recalls BeeGentle Topical Anesthetic Due to cGMP Violations

    CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.

    Product
    BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Me
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-12-19

    CAO Group Recalls SHEER DesenZ Desensitizing Treatment Due to cGMP Violations

    CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.

    Product
    SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
    Category
    Distribution
    0 states