Recalls / Class II
Class IID-0037-2021
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.
- Affected lot / code info
- Lot #: 072120, Exp. 01/21/2022
Why it was recalled
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Recalling firm
- Firm
- Genesis Partnership Company SA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Km 19.5 Carretera Al Pacifico, Bodega 28, N/A, Villa Nueva, N/A N/A, Guatemala
Distribution
- Quantity
- 33,480 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-09-11
- FDA classified
- 2020-10-19
- Posted by FDA
- 2020-10-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0037-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.