One Lot of Bupivacaine Hydrochloride Injection USP and One Lot of Lidocaine HCl Injection USP by Hospira Recall - Due to Mislabeling

TOPIC: One Lot of Bupivacaine Hydrochloride Injection USP, 0.5% and One Lot of Lidocaine HCl Injection USP, 1% by Hospira: Recall - Due to Mislabeling

AUDIENCE: Health Professional, Risk Manager

ISSUE: Hospira is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 0.5% 30 mL and lot EG8933 of Lidocaine HCl Injection USP, 1% 30 mL, due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. This issue was identified as part of the investigation of a confirmed customer report.

Hospira’s assessment of the potential risk to patients concluded that the use of the impacted product is likely to cause adverse events of moderate to high severity. 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 low oxygen and/or elevated carbon dioxide in the blood, too much acid in the body fluids, and temporary cessation of breathing; heart abnormalities such as heart contraction and/or relaxation issues, irregular heartbeat, slower than normal heart rate, abnormal heart rhythm in which the ventricles of the heart quiver instead of pumping normally, cardiac arrest and cardiac flatline.

To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

BACKGROUND: Bupivacaine Hydrochloride Injection USP, 0.5% is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.

Lidocaine HCl Injection USP, 1% USP is indicated for the production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks when the accepted procedures for these techniques as described in standard textbooks are observed.

RECOMMENDATIONS: 

• Hospira has notified wholesalers, distributors, retailers, and hospitals by mail to arrange for return of any recalled product.
• Wholesalers, distributors or retailers with an existing inventory of the lot, which is being recalled, should stop administration and distribution and quarantine immediately.
• Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Read the full recall.