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

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

Recall Summary

Recall Number D-1348-2022
Classification Class II - Moderate risk
Date Initiated August 4, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corporation
Location Deerfield, IL
Product Type Drugs
Quantity 85,680 bags

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.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

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

Other Recalls from Baxter Healthcare Corporation

Recall # Classification Product Date
D-0296-2026 Class II Sterile Water for Irrigation, 250 mL, Single-Do... Dec 22, 2025
D-0596-2025 Class II Acetaminophen Injection 1000 mg/100 mL (10 mg/m... Aug 20, 2025
D-0039-2025 Class II Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL)... Oct 30, 2024
D-0649-2024 Class I Heparin (Heparin Sodium in 0.9% Sodium Chloride... Aug 1, 2024
D-0587-2024 Class II Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dial... Jun 17, 2024

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.