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The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.
Hospira, a Pfizer company, announced on May 4, 2021 that it was voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL. The recall was initiated because of incorrect labeling of a portion of each lot as the other product, which was identified as part of the investigation of a confirmed customer report.
Use of the impacted product, according to Hospira, may cause moderate to highly severe adverse events. Administration of 1% lidocaine instead of 0.5% bupivacaine may lead to the patient being underdosed, which may lead to inadequate pain management and failure of surgical anesthesia, according to the company. Administration of 0.5% bupivacaine instead of 1% lidocaine may lead to an overdose of bupivacaine, which could cause seizures, respiratory abnormalities, and heart abnormalities.
According to Hospira, 0.5% Bupivacaine Hydrochloride Injection, USP is used as local or regional anesthesia or analgesia for surgical procedures, diagnostic and therapeutic procedures, and obstetrical procedures. The other product, 1% Lidocaine HCl Injection, USP, is used as local or regional anesthesia by infiltration techniques, intravenous regional anesthesia by peripheral nerve block techniques, and by central neural techniques.
The impacted lots were distributed Dec. 29, 2020 to April 15, 2021 nationwide to wholesalers, distributors, retailers, and hospitals in the United States, Puerto Rico, and Guam. More information about the recalled lots can be found on FDA.gov. The company reports that no adverse events have been reported as of the date of the recall. Adverse events may be reported to FDA through the agency’s MedWatch program.