United States
Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL
Reason of the recall: Due to mislabeling
FDA Recall date: May 04, 2021
Recall details: Hospira, Inc., a Pfizer company, is voluntarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level 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, Inc. has not received reports of any adverse events associated with this issue for these lots. 0.5% Bupivacaine Hydrochloride Injection, USP 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. 1% Lidocaine HCl Injection, 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.
The NDC, Lot Number, Expiration Date, Strength and Configuration details for 0.5% Bupivacaine Hydrochloride Injection, USP and 1% Lidocaine HCl Injection, USP are in the table below and a photo of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers, distributors, retailers, and hospitals in the United States, Puerto Rico and Guam from December 29, 2020 to April 15, 2021.
- 0.5% Bupivacaine Hydrochloride Injection, USP, Single Dose Teartop Vial. NDC: Vial: 0409-1162-19 Tray: 0409-1162-02. Lot number: EG6023. Expiration Date: 01 July 2022. Strength: 0.5%, 150 mg/30 mL (5 mg/mL). Configuration/ Count: Case Pack 2 x 25 Vials.
- 1% Lidocaine HCl Injection, USP Single Dose Teartop Vial. NDC: Vial: 0409-4279-16 Tray: 0409-4279-02. Lot number: EG8933. Expiration Date: 01 Aug 2022. Strength: 1%, 300 mg/30 mL (10 mg/mL). Configuration/ Count: Case Pack 2 x 25 Vials.
Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. 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. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you.
Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Check the full recall details on
www.fda.gov
Source: FDA
