May 4, 2021
Hospira, Inc., a subsidiary of Pfizer, has voluntarily recalled one lot of 0.5% Bupivacaine Hydrochloride (HCl) Injection, USP 30mL, and one lot of 1% Lidocaine HCl Injection, USP 30mL, to the hospital/institution level due to mislabeling. Following a customer complaint, Hospira found a portion of each lot was incorrectly labeled as the other product (e.g., some bupivacaine was mislabeled as lidocaine and vice versa).
The affected bupivacaine is indicated for use in adults to provide local or regional anesthesia or analgesia. The affected lidocaine is indicated to produce local or regional anesthesia.
According to Hospira, using the affected product carries a risk of moderate to highly severe adverse events. Patients receiving 1% lidocaine who were meant to be given 0.5% bupivacaine could experience insufficient pain management and/or failure of surgical anesthesia. Giving 0.5% bupivacaine when 1% lidocaine was meant to be administered could lead to an overdose of bupivacaine. Bupivacaine overdoses can lead to seizures, respiratory abnormalities, and heart abnormalities, and could be fatal. As of the date of the recall, Hospira had not received reports of any adverse events associated with the affected lots.
Hospira has notified wholesalers, distributors, retailers, and hospitals by mail to arrange for return of the recalled product. Existing inventory of the lot should be quarantined immediately. Hospitals and institutions should inform healthcare professionals within their organizations of the recall.
Any Hospira customers who have questions regarding the recall should call Stericycle at 1-800-805-3093 for additional assistance. Healthcare professionals can call Pfizer with medical questions related to the recall at 1-800-438-1985, option 3. To report adverse events that may be related to the recall, healthcare professionals can call Pfizer at 1-800-438-1985, option 1, and/or submit a report to the U.S. FDA through the agency’s MedWatch program.
A copy of the recall announcement can be found on the FDA’s website.
There is no impact to members through Benecard Central Fill.