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Lidocaine FDA Alerts

The FDA Alerts below may be specifically about lidocaine or relate to a group or class of drugs which include lidocaine.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for lidocaine

Hospira Recalls 0.5% Bupivacaine Injection and 1% Lidocaine Injection, Due to Mislabeling

May 04, 2021 -- 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.

Product NDC Lot Number Expiration Date Strength Configuration/ Count
0.5%
Bupivacaine Hydrochloride Injection, USP, Single Dose Teartop Vial
Vial:
0409-1162-19
Tray:
0409-1162-02
EG6023 01 July
2022
0.5%, 150 mg/30
mL (5 mg/mL)
Case Pack 2 x 25 Vials
1% Lidocaine HCl Injection, USP Single Dose Teartop Vial Vial:
0409-4279-16
Tray:
0409-4279-02
EG8933 01 Aug
2022
1%, 300 mg/30
mL (10 mg/mL)
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.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

Contact Contact Information Areas of Support
Pfizer Medical Information 1-800-438-1985, option 3
(9am to 5pm ET Monday through Friday)
Medical questions
regarding the product
Pfizer Safety 1-800-438-1985, option 1 (24
hours a day 7 days per week)
To report adverse
events or product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. 

Source: FDA


Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

ISSUE: Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

BACKGROUND:
This lot (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) was distributed nationwide from May 2014 through June 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions. 

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. This recall is being carried out to the medical facility/retail level (both human and veterinary). Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of these products in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-877-546-5069 between the hours of 8am to 5pm ET, Monday through Friday. 

Healthcare 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: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  •     Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
     

    [10/17/2014 - Firm Press Release - Hospira, Inc.]
     

Lidocaine HCl Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

ISSUE: Hospira, Inc. is recalling one lot of Lidocaine HCl Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.

Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

BACKGROUND: Lidocaine is packaged 10 units per carton / 180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013.  

RECOMMENDATION: Anyone with existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira is notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET). For clinical inquiries, refer to the Firm Press Release.

Healthcare 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:

[07/29/2014 - Firm Press Release - Hospira, Inc]


Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

[Posted 03/14/2014]

ISSUE: Hospira, Inc. is recalling one lot (# 25-090-DK) of 1% Lidocaine HCl Injection which is contained in the Merit Medical Systems Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. If oxidized stainless steel particulate is undetected, there is a potential to be injected and/or result in delay in therapy. These effects have the potential to result in serious life-threatening complications requiring medical intervention.

The affected products were manufactured from April 29, 2013 through August 20, 2013 and distributed from April 30, 2013 through September 20, 2013. See Lot Numbers for Custom Procedural Trays or Kits.

BACKGROUND: The presence of oxidized stainless steel particulate may potentially put a patient at risk from a strong magnetic field exposure such as with magnetic resonance imaging (MRI). If a metal particle in the lung becomes dislodged and pulled through tissue, possibly causing a collapsed lung (pneumothorax) or blood in the space between the chest wall (hemothorax), urgent and significant medical intervention may be required. The presence of oxidized stainless steel particulate could also result in blood clots in the lung and a stroke.

RECOMMENDATION: On September 30, 2013, Merit Medical sent an “URGENT PRODUCT RECALL NOTICE” by FedEx to all its affected customers. The notice identified the affected product, description of the problem and recommended user actions to be taken.

Please see detailed instructions for Distributors, Hospitals, Risk Managers, Material Managers, and actions to be taken by the customer in the FDA Class I Recall Notice.

[03/14/2014 - Recall Notice - FDA]
 


Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter

ISSUE: Hospira initiated a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution.

If particulate goes undetected and solution is administered, the particle may potentially block the infusion of the solution to the patient, resulting in a delay in therapy. If smaller pieces of the particulate break off and become free floating within the solution, they may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Chronically, following sequestration, local granuloma formulation is possible. In consideration of the reddish orange color of the particulate, if there is iron within the particle that is infused, it may put a patient at risk when undergoing MRI (strong magnetic field exposure), as the particle could potentially be dislodged and be pulled through tissue, causing local inflammation and tissue trauma.

BACKGROUND: The recalled lot was distributed to distributors/wholesalers, hospitals, and pharmacies located in AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MS, MO, NV, NJ, NC, OH, OK, PA, TN, TX, UT, VA, WA, and WI between September 2013 through October 2013. Lidocaine is packaged 10 units per carton/180 units per case in single dose glass fliptop vials.

RECOMMENDATION: Anyone with an existing inventory should immediately stop use and quarantine any affected product and return the product to Stericycle. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-855-695-8596 between 8 a.m. and 5 p.m., ET, Monday through Friday.

Healthcare 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:


[12/23/2013 - Firm Press Release - Hospira]


Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

UPDATED 10/21/2013 with related product recall information

Hospira announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. See firm's press release below for further information.

[Posted 10/04/2013]

AUDIENCE: Health Professional, Risk Manager

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. 

Healthcare 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:

[10/04/2013 - Firm Press Release]

[10/17/2013 - Firm Press Release]


1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. 

Healthcare 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:

[10/04/2013 - Firm Press Release]


Local Anesthetics, Continuously Infused (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis

FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics (marketed as bupivacaine, chloroprocaine, lidocaine, mepivacaine, procaine, ropivacaine) with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement).

Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.

This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references.

[11/13/2009 - Information for Healthcare Professionals - FDA]

    

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