D-1356-2022 Class II Terminated
FDA drug recall D-1356-2022 was initiated by Aire-Master of America Inc on July 15, 2022 and is designated Class II. Reason for recall: CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. The recall status is terminated (terminated February 19, 2023). Affected quantity: 9,176 cartons.
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
- 9,176 cartons
Product Description
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
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 46076 Lot 722896-exp 07/22, 722996-exp 07/22