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Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Cont...

FDA Recall #D-1348-2022 — Class II — August 4, 2022

Recall #D-1348-2022 Date: August 4, 2022 Classification: Class II Status: Terminated

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.

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

85,680 bags

Distribution

Nationwide in the USA

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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