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Recall Observatory FDA recall evidence

Drug 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

D-1348-2022

August 04, 2022

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 90699
Status
Terminated
Classification
Class II
Quantity
85,680 bags
Official record key
drug-enforcement:D-1348-2022

Official wording

Reason: 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.

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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.