Recalls / Class II
Class IID-1500-2019
Product
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 lot / code info
- All lots remaining within expiry.
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.
Recalling firm
- Firm
- Pharma-Natural Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, Florida 33014
Distribution
- Quantity
- 1032 jars
- Distribution pattern
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-06-21
- FDA classified
- 2019-07-23
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1500-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.