Class II · Moderate risk Terminated
Hydroquinone USP
Reason Finished product specification did not meet USP specifications.
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
What was recalled
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
- Recalling firm
- Eb5 Corporation
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0908-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Hydroquinone recalls
See all
Class III · Low risk Terminated
Hydroquinone
Reason Subpotency: one product for active ingredient assay and another one for preservative assay
Class II · Moderate risk Terminated
DCL AHA Lightening Gel
Reason GMP Deviations
Class II · Moderate risk Terminated
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Dermanak original crema blanqueador
Reason 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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