Drug 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.
D-1500-2019
Product summary
- Event
- Event 83190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1032 jars
- Official record key
drug-enforcement:D-1500-2019
Official wording
Reason: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Code information: All lots remaining within expiry.
Distribution pattern: Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations