Status
Terminated
Drug Enforcement D-0449-2023
CGMP DEVIATIONS
Classification
Class II
Report Date
March 15, 2023
Termination Date
June 21, 2023
Product Information
- Product description
- 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
- Product quantity
- a) 23,993 plastic jar/folding carton and b) 34,284 plastic jar/folding carton
- Reason for recall
- CGMP DEVIATIONS
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Ecometics, Inc.
- Address
-
19 Concord St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0449-2023
- Event ID
- 91719
- Recall initiation date
- February 24, 2023
- Center classification date
- March 8, 2023
- Code info
- Lot #: a) 0E344A /AA, exp. date N/A; b) 2E243A, Exp. Aug-25
- More code info
- —