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- Recall Enforcement Event ID: 86579
Recall Enforment Report D-0085-2021
Recall Details
Multi event Drug Recall Enforcement Report Class II voluntary initiated by Milbar Laboratories, Inc., originally initiated on 10-09-2020 for the product DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471 The product was recalled due to 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.
Recall Enforcement Reports
| Recall Number | Recall Initiation Date | Report Date | Recall Classification | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|---|
| D-0085-2021 | 10-09-2020 | 11-25-2020 | Class II | 1,608 bottles | DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471 | GMP Deviations | Terminated |
| D-0096-2021 | 10-09-2020 | 11-25-2020 | Class II | 198.8 kg | Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics | GMP Deviations | Terminated |
| D-0091-2021 | 10-09-2020 | 11-25-2020 | Class II | 2,655 bottles | MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN | GMP Deviations | Terminated |
| D-0086-2021 | 10-09-2020 | 11-25-2020 | Class II | 1,815 bottles | DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120 | GMP Deviations | Terminated |
| D-0094-2021 | 10-09-2020 | 11-25-2020 | Class II | 2,335 bottles | DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | GMP Deviations | Terminated |
| D-0090-2021 | 10-09-2020 | 11-25-2020 | Class II | 3,692 tubes | (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 | GMP Deviations | Terminated |
| D-0084-2021 | 10-09-2020 | 11-25-2020 | Class II | 7,591 bottles | 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 | GMP Deviations | Terminated |
| D-0087-2021 | 10-09-2020 | 11-25-2020 | Class II | 1,225 bottles | 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 | GMP Deviations | Terminated |
| D-0092-2021 | 10-09-2020 | 11-25-2020 | Class II | 4,855 tubes | Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226 | GMP Deviations | Terminated |
| D-0093-2021 | 10-09-2020 | 11-25-2020 | Class II | 2,638 plastic jars | Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads | GMP Deviations | Terminated |
| D-0089-2021 | 10-09-2020 | 11-25-2020 | Class II | 2,664 tubes | (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 | GMP Deviations | Terminated |
| D-0083-2021 | 10-09-2020 | 11-25-2020 | Class II | 4,878 tubes | DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627 | GMP Deviations | Terminated |
| D-0088-2021 | 10-09-2020 | 11-25-2020 | Class II | 5,312 bottles | (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 | GMP Deviations | Terminated |
| D-0095-2021 | 10-09-2020 | 11-25-2020 | Class II | 927 tubes | DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | GMP Deviations | Terminated |
Recall Enforcement Report D-0085-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0085-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,608 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: LW110-3, Exp. Date Nov-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0096-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0096-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 198.8 kg Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: HV349 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0091-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0091-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,655 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: DX278, Exp. Date Apr-23 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0086-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0086-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,815 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: KV092-3, Exp. Date Nov-21 Lot #: FX456-7, Exp. Date Jun-23 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0094-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0094-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,335 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot # HV093-6, exp. date Aug-21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0090-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0090-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- (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
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,692 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: AW761-9, Exp. Date Jan-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0084-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0084-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 7,591 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot # MV098-4, Exp. Date Dec-21 Lot #: JW995, Exp. Date Sep-22 Lot #: Fx381, Exp. Date Jun-23 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0087-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0087-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- 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
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 1,225 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: DW913-9, Exp. Date Apr-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0092-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0092-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4,855 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: DW827-4, Exp. Date Mar-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0093-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0093-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,638 plastic jars Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: CW828-0, Exp. Date Mar-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0089-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0089-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- (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
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 2,664 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: MV678, Exp. Date Dec-21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0083-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0083-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4,878 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot # FW937, Exp. Date Jun-22 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0088-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0088-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- (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
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 5,312 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: GW905-5, Exp. Date Jul-22 Lot #: KV428-3, Exp. Date Oct-21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Recall Enforcement Report D-0095-2021
- Event ID
- 86579 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0095-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
- Reason For Recall
- GMP Deviations What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 927 tubes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 11-25-2020
- Recall Initiation Date
- 10-09-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 01-04-2023 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Milbar Laboratories, Inc.
- Code Info
- Lot #: FX432-5, Exp. Date June-21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
