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FDA (Drug enforcement)Recalled 2022-08-04closedclass ii

Baxter Healthcare Corporation: 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,

Is my product affected?

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

  • Brand ACETAMINOPHEN

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation has recalled 85,680 bags of Acetaminophen Injection (10 mg/mL, 1,000 mg/100 mL) distributed nationwide in the USA. The recall was issued because the product was shipped in refrigerated trucks with pallet labels instructing recipients to refrigerate upon arrival, despite the medication being labeled for storage at controlled room temperature. This temperature abuse during distribution affects multiple lots with expiration dates ranging from October 2022 to November 2023.

The recall record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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 Quantity: 85,680 bags Lot/code info: Lots: 20K19G64T1, Exp 10/31/2022; 21K23G65, 21K25G65, 21K26G65, 21K29G67, Exp 10/31/2023; 21L10G65, 21L13G66, 21L14G66, 21L15G65, Exp 11/30/2023

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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