RecallRadar

FDA Drug recall D-1358-2022

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa…

On 2022-08-24 the FDA classified a Class II recall of Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa… by Aire Master, citing CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1358-2022
ClassificationClass II
Statusterminated
Initiated2022-07-15
Published2022-08-24
Last updated2026-09-13 11:52 UTC
CompanyAire Master
DistributionFL, IA, IL, NJ

Product

Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.

Reason

CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.

Identifiers

code_infoProduct Number 46112, Lots 722782 -exp 08/22

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1358-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.