Multi-event November 2018 FDA Recall Drug by Cao Group, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Cao Group, Inc. on November 16, 2018 for the product Drug. The FDA reported the reason for recall as cgmp violations noted during the firm's most recent inspection.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0290-2019 TERMINATED D-0293-2019 TERMINATED D-0291-2019 TERMINATED D-0292-2019 TERMINATED

Recall Number: D-0290-2019

Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Initiated
11-16-2018
Reported
12-19-2018
Quantity
115 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81556
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CAO Group, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 170831, EXP 8/31/2019; 180704, EXP 7/04/2020

Recall Number: D-0293-2019

Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Initiated
11-16-2018
Reported
12-19-2018
Quantity
602 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81556
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CAO Group, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : 170626, EXP 6/26/2019; 171214, EXP 1214/2019.

Recall Number: D-0291-2019

Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Initiated
11-16-2018
Reported
12-19-2018
Quantity
71 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81556
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CAO Group, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 170626, EXP 6/26/2019; and 180131, EXP 01/31/2020

Recall Number: D-0292-2019

Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Initiated
11-16-2018
Reported
12-19-2018
Quantity
803 units (400 kit and 403 30 ml bottles)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81556
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CAO Group, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-27-2020
Product Description About Product Description
Full technical description of the 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) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084

Batch or Lot Expiration Information

Lot# Lots #: a) 110216, EXP 11/02/18; 170524, EXP 5/24/2019; 171116, EXP 11/16/2019; 180319, EXP 3/19/2020; b)110216, EXP 11/02/2018; 170323, EXP 3/23/2019; 180109, EXP 1/09/2020