Drug product
Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars
D-0449-2023
Product summary
- Firm
- Ecometics, Inc.
- Event
- Event 91719
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 23,993 plastic jar/folding carton and b) 34,284 plastic jar/folding carton
- Official record key
drug-enforcement:D-0449-2023
Official wording
Reason: CGMP DEVIATIONS
Code information: Lot #: a) 0E344A /AA, exp. date N/A; b) 2E243A, Exp. Aug-25
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP DEVIATIONS