Drug product
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
D-0908-2018
Product summary
- Firm
- Eb5 Corporation
- Event
- Event 80359
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,632 tubes
- Official record key
drug-enforcement:D-0908-2018
Official wording
Reason: Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Code information: Batch B4276A EXP 03/2019
Distribution pattern: Distributed Nation Wide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-specification