Drug recall: DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven…
Class II FDA enforcement event 86579. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
GMP Deviations
Class II, in the words of FDA
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
Milbar Laboratories, Inc. started this drug recall on 9 Oct 2020. The firm address in the FDA record is in East Haven, CT. FDA put the recall in Class II. FDA event 86579 has 14 product records. The first FDA enforcement report date is 25 Nov 2020. The record gives the status Terminated, with the termination date 4 Jan 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed throughout the United States, including Puerto Rico and internationally.
Recalling firm
Milbar Laboratories, Inc., East Haven, CT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0083-2021 | DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627 | 4,878 tubes | Class II | Terminated | 25 Nov 2020 |
| D-0084-2021 | 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 | 7,591 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0085-2021 | DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471 | 1,608 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0086-2021 | DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120 | 1,815 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0087-2021 | 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 | 1,225 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0088-2021 | (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 | 5,312 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0089-2021 | (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 | 2,664 tubes | Class II | Terminated | 25 Nov 2020 |
| D-0090-2021 | (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 | 3,692 tubes | Class II | Terminated | 25 Nov 2020 |
| D-0091-2021 | MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl. oz. (30mL) bottles, MD Professional LLC, Minneapolis, MN | 2,655 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0092-2021 | Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226 | 4,855 tubes | Class II | Terminated | 25 Nov 2020 |
| D-0093-2021 | Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads | 2,638 plastic jars | Class II | Terminated | 25 Nov 2020 |
| D-0094-2021 | DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | 2,335 bottles | Class II | Terminated | 25 Nov 2020 |
| D-0095-2021 | DCL Clear Skin Anti-Blemish Hydrator (2% Salicylic Acid), 50ml/1.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA | 927 tubes | Class II | Terminated | 25 Nov 2020 |
| D-0096-2021 | Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics | 198.8 kg | Class II | Terminated | 25 Nov 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2020
- 342
- Share of these events in Class II
- 64%
- Product records in this event
- 14Median of the firm: 4
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 May 2018 | T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic La | Drug | Class III | 2 |
| 4 May 2018 | B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT | Drug | Class II | 4 |
Official channels
- FDA enforcement report D-0083-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86579. https://recallregister.com/fda/ii/86579/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed throughout the United States, including Puerto Rico and internationally.
- What quantity of product is in FDA event 86579?
- The event has 14 product records. The first record gives this quantity:
4,878 tubes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2020 have the same class?
- 64% of the 342 drug events that started in 2020 are in Class II.