Medications & Supplements/Prescription Drugs

Baxter Acetaminophen Injection Recalled for Incorrect Storage Temperature Labeling

Agency Publication Date: August 16, 2022

Summary

Baxter Healthcare Corporation is recalling 85,680 bags of Acetaminophen Injection (1,000 mg per 100 mL) used for intravenous pain relief. The product was shipped in refrigerated trucks with pallet labels incorrectly instructing healthcare facilities to refrigerate the medication upon arrival, even though it should be stored at controlled room temperature. No incidents or injuries have been reported to date.

Risk

Storing this medication at the wrong temperature could potentially affect its stability or performance. While this is primarily a shipping and labeling error, using improperly stored medication may pose a risk to patient safety.

What You Should Do

This recall affects Baxter Acetaminophen Injection (10 mg/mL) sold in 100 mL VIAFLO single-dose container bags with NDC 36000-306-60.
Identify recalled bags by checking the lot numbers and expiration dates: 20K19G64T1 (Exp 10/31/2022); 21K23G65, 21K25G65, 21K26G65, 21K29G67 (Exp 10/31/2023); 21L10G65, 21L13G66, 21L14G66, 21L15G65 (Exp 11/30/2023).
Stop using the recalled product. Contact Baxter Healthcare Corporation or your medical distributor to arrange for the return of any remaining inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this recall.

Your Remedy Options

Other Action

Return to manufacturer

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Acetaminophen Injection (1,000 mg/100 mL)

Variants: 10 mg/mL, 100 mL VIAFLO container bag, Single Dose Container

Lot Numbers:

20K19G64T1 (Exp 10/31/2022)

21K23G65 (Exp 10/31/2023)

21K25G65 (Exp 10/31/2023)

21K26G65 (Exp 10/31/2023)

21K29G67 (Exp 10/31/2023)

21L10G65 (Exp 11/30/2023)

21L13G66 (Exp 11/30/2023)

21L14G66 (Exp 11/30/2023)

21L15G65 (Exp 11/30/2023)

NDC:

36000-306-60

For Intravenous Use Only; Rx Only; Manufactured by Baxter Healthcare Corporation.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90699

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 85,680 bags

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Baxter Acetaminophen Injection (10 mg/mL) sold in 100 mL VIAFLO single-dose container bags with NDC 36000-306-60.

Identify recalled bags by checking the lot numbers and expiration dates: 20K19G64T1 (Exp 10/31/2022); 21K23G65, 21K25G65, 21K26G65, 21K29G67 (Exp 10/31/2023); 21L10G65, 21L13G66, 21L14G66, 21L15G65 (Exp 11/30/2023).

Stop using the recalled product. Contact Baxter Healthcare Corporation or your medical distributor to arrange for the return of any remaining inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information regarding this recall.

Affected Products

Product: Acetaminophen Injection (1,000 mg/100 mL)

Variants: 10 mg/mL, 100 mL VIAFLO container bag, Single Dose Container

Lot Numbers:

20K19G64T1 (Exp 10/31/2022)

21K23G65 (Exp 10/31/2023)

21K25G65 (Exp 10/31/2023)

21K26G65 (Exp 10/31/2023)

21K29G67 (Exp 10/31/2023)

21L10G65 (Exp 11/30/2023)

21L13G66 (Exp 11/30/2023)

21L14G66 (Exp 11/30/2023)

21L15G65 (Exp 11/30/2023)

NDC:

36000-306-60

For Intravenous Use Only; Rx Only; Manufactured by Baxter Healthcare Corporation.