Drug product
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
D-0667-2024
Product summary
- Event
- Event 95390
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 bottles
- Official record key
drug-enforcement:D-0667-2024
Official wording
Reason: CGMP deviations
Code information: Lot #: 042224-L1, Exp. Date 04/22/2025
Distribution pattern: Product was sent to one distributor in North Carolina.
Derived failure modes
-
Manufacturing or process control
CGMP deviations