D-0451-2023 Class II Terminated
FDA drug recall D-0451-2023 was initiated by Ecometics, Inc. on February 24, 2023 and is designated Class II. Reason for recall: CGMP DEVIATIONS The recall status is terminated (terminated June 21, 2023). Affected quantity: 34,320 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- February 24, 2023
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34,320 bottles
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
Reason for Recall
CGMP DEVIATIONS
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 2E055A, Exp. Date Feb-2025