August 2022 FDA Recall Acetaminophen by Baxter Healthcare Corporation
D-1348-2022 - Temperature Abuse

This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on August 4, 2022 for the product Acetaminophen. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1348-2022

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.
Initiated
08-04-2022
Reported
08-24-2022
Quantity
85,680 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-16-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lots: 20K19G64T1, Exp 10/31/2022; 21K23G65, 21K25G65, 21K26G65, 21K29G67, Exp 10/31/2023; 21L10G65, 21L13G66, 21L14G66, 21L15G65, Exp 11/30/2023

Affected Packages Involved in this Recall

36000-306-60 Acetaminophen
36000-372-40 Acetaminophen