Status
Terminated
Drug Enforcement D-0451-2023
CGMP DEVIATIONS
Classification
Class II
Report Date
March 15, 2023
Termination Date
June 21, 2023
Product Information
- Product description
- Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155
- Product quantity
- 34,320 bottles
- 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-0451-2023
- Event ID
- 91719
- Recall initiation date
- February 24, 2023
- Center classification date
- March 8, 2023
- Code info
- Lot #: 2E055A, Exp. Date Feb-2025
- More code info
- —