Drug Safety Alerts

Acetaminophen Voluntary Recall

9/06/2022

On September 6, 2022, Baxter Healthcare Corporation issued a consumer-level recall of Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag. This recall was issued due to possible improper temperature storage conditions. The product distributed in refrigerated trucks with labels attached to pallets indicating "refrigerate upon arrival". Additionally, some of the affected lots were shipped under refrigerated conditions. This may lead to customers storing the product in a refrigerated state upon receipt. Per the primary product labeling, the product should be stored in a controlled room temperature environment and should not be refrigerated or frozen.

We’ve provided a list of the affected products HERE.

Baxter has advised that if this product is stored in refrigerated conditions for longer than one month, there is a potential for the solution to generate visible or sub-visible particulate matter. If particulate matter is not detected prior to use, it may enter the vascular system of the patient. Particulate matter that enters the vascular system could result in thromboembolic, inflammatory, infective, or allergic reactions. According to Baxter, there have been no reports of adverse events related to this issue.

Baxter Healthcare Corporation advises all consumers that have this recalled product to stop using and return any remaining product.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies. CVS Specialty and CVS Pharmacy indicated they had no purchases of the affected products during the time the affected lot was in distribution.

For more information, please call Baxter Healthcare Corporation at 1-800-437-5176, between the 8:00 AM and 5:00 PM CST, Monday-Friday. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.