Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
DCL AHA Lightening Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
Drug: Hydroquinone
- Recalling firm
- Milbar Laboratories, Inc.
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0085-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroquinone recalls
See all
Class III · Low risk
Hydroquinone
Subpotency: one product for active ingredient assay and another one for preservative assay
Class II · Moderate risk
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Dermanak original crema blanqueador
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Other recalls by Milbar Laboratories, Inc.
All 2020 recalls
Class II · Moderate risk
Salicylic Acid Shampoo 3%
GMP Deviations
Class II · Moderate risk
DCL Clear Skin Anti-Blemish Hydrator
GMP Deviations
Class II · Moderate risk
DCL Alpha Beta Gel Toner
GMP Deviations
Class II · Moderate risk
Willa Pore Perfector
GMP Deviations
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