Drug Safety Alerts

Bupivacaine Hydrochloride and Lidocaine HCl Injections Class I Recall

6/11/2021

On June 11, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a Class I recall of Bupivacaine Hydrochloride and Lidocaine HCl Injections. This recall is being issued due to a label mix-up. Some vials that were labeled to contain 0.5% Bupivacaine Hydrochloride Injection may contain 1% Lidocaine HCl Injection and some vials that were labeled to contain 1% Lidocaine HCl Injection may contain 0.5% Bupivacaine Hydrochloride Injection.

A complete list of the affected products can be found here.

Hospira advises that it has completed a Health Hazard Assessment, which concluded that use of the impacted products are likely to cause moderate to high severity adverse events.

According to Hospira, if 1% lidocaine is administered to the patient instead of 0.5% bupivacaine, the patient may be underdosed, leading to lack of efficacy with potential outcomes such as inadequate pain management and failure of surgical anesthesia. If 0.5% bupivacaine is administered to the patient instead of 1% lidocaine, an overdose of bupivacaine may occur, which could lead to potential outcomes such as seizures, respiratory abnormalities including hypoxia, hypercarbia, acidosis, and apnea, cardiovascular abnormalities such as myocardial depression, cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, and cardiac arrest with potentially life-threatening and/or fatal consequences.

Hospira concluded that the overall potential risk to the patient arising from this issue is considered to be high for both mislabeling scenarios based on current information available from the investigation.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who received affected product to contact their prescriber.

For more information about this recall, please call Bupivacaine Hydrochloride and Lidocaine HCl Injections. 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.