Drug product
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
D-0037-2021
Product summary
- Event
- Event 86427
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33,480 bottles
- Official record key
drug-enforcement:D-0037-2021
Official wording
Reason: CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Code information: Lot #: 072120, Exp. 01/21/2022
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations