Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Dermanak original crema blanqueador
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.
Affected NDC
63788-0108-02
Compare with the code on your package — it is the most precise check available.
Drug: Hydroquinone
- Recalling firm
- Pharma-Natural Inc.
- NDC code
- 63788-108-02
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1500-2019 · 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
DCL AHA Lightening Gel
GMP Deviations
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
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Other recalls by Pharma-Natural Inc.
All 2019 recalls
Class II · Moderate risk
Workvie Instant Pain Relieving Roll On
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
Neogen-D
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
Sorbugen Nr
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
Tusslin
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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