FDA recall D-1348-2022

Product

Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60

Reason for recall

Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-08-04

Report date

2022-08-24

Termination date

2024-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1348-2022