PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 24, 2022 Initiated: August 4, 2022 #D-1348-2022

Product Description

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.

Details

Units Affected
85,680 bags
Distribution
Nationwide in the USA
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Baxter Healthcare Corporation. Units affected: 85,680 bags.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 24, 2022. Severity: Moderate. Recall number: D-1348-2022.