Multi-event October 2020 FDA Recall Drug by Milbar Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Milbar Laboratories, Inc. on October 9, 2020 for the product Drug. The FDA reported the reason for recall as gmp deviations. The product was distributed in Product was distributed throughout the United States, including Puerto Rico and internationally. and the recall is currently terminated.

Reported Recall Events

D-0096-2021 TERMINATED D-0091-2021 TERMINATED D-0086-2021 TERMINATED D-0094-2021 TERMINATED D-0090-2021 TERMINATED D-0085-2021 TERMINATED D-0092-2021 TERMINATED D-0084-2021 TERMINATED D-0087-2021 TERMINATED D-0093-2021 TERMINATED D-0089-2021 TERMINATED D-0083-2021 TERMINATED D-0088-2021 TERMINATED D-0095-2021 TERMINATED

Recall Number: D-0096-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
198.8 kg

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics

Batch or Lot Expiration Information

Lot# : HV349

Recall Number: D-0091-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
2,655 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN

Batch or Lot Expiration Information

Lot# : DX278, Exp. Date Apr-23

Recall Number: D-0086-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
1,815 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120

Batch or Lot Expiration Information

Lot# : KV092-3, Exp. Date Nov-21
Lot# : FX456-7, Exp. Date Jun-23

Recall Number: D-0094-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
2,335 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Batch or Lot Expiration Information

Lot# HV093-6, exp. date Aug-21

Recall Number: D-0090-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
3,692 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Batch or Lot Expiration Information

Lot# : AW761-9, Exp. Date Jan-22

Recall Number: D-0085-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
1,608 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471

Batch or Lot Expiration Information

Lot# : LW110-3, Exp. Date Nov-22

Recall Number: D-0092-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
4,855 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226

Batch or Lot Expiration Information

Lot# : DW827-4, Exp. Date Mar-22

Recall Number: D-0084-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
7,591 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 0357486500853

Batch or Lot Expiration Information

Lot# MV098-4, Exp. Date Dec-21
Lot# : JW995, Exp. Date Sep-22
Lot# : Fx381, Exp. Date Jun-23

Recall Number: D-0087-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
1,225 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947

Batch or Lot Expiration Information

Lot# : DW913-9, Exp. Date Apr-22

Recall Number: D-0093-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
2,638 plastic jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads

Batch or Lot Expiration Information

Lot# : CW828-0, Exp. Date Mar-22

Recall Number: D-0089-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
2,664 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
(Malin + Goetz) Salicylic Gel (2% Salicylic Acid) 0.5 fl.oz. 15 mL tube, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Batch or Lot Expiration Information

Lot# : MV678, Exp. Date Dec-21

Recall Number: D-0083-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
4,878 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627

Batch or Lot Expiration Information

Lot# FW937, Exp. Date Jun-22

Recall Number: D-0088-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
5,312 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
(Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

Batch or Lot Expiration Information

Lot# : GW905-5, Exp. Date Jul-22
Lot# : KV428-3, Exp. Date Oct-21

Recall Number: D-0095-2021

Reason for Recall
GMP Deviations
Initiated
10-09-2020
Reported
11-25-2020
Quantity
927 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86579
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.
Milbar Laboratories, 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.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-04-2023
Product Description About Product Description
Full technical description of the product.
DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA

Batch or Lot Expiration Information

Lot# : FX432-5, Exp. Date June-21