D-1359-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 24, 2022
- Initiation Date
- July 15, 2022
- Termination Date
- February 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,064 bottles
Product Description
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Reason for Recall
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Distribution Pattern
Florida, Illinois, Iowa, New Jersey
Code Information
Product Number 46111, Lot 722781-exp 09/22