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bupivacaine FDA Alerts

The FDA Alert(s) below may be specifically about bupivacaine or relate to a group or class of drugs which include bupivacaine.

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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for bupivacaine

0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

Aug 5, 2016

Audience: Pharmacy, Risk Manager, OBGYN, Dentistry

ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.

BACKGROUND: 0.25% Bupivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.

The product is packaged 50 units of 30 mL Single-use Teartop Vials per case, (25 Bottles per tray, two trays per case). The lot was distributed nationwide in the U.S. to wholesalers and hospitals between December 2015 and January 2016. 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. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level.

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:


[08/05/2016 - Press Release - Hospira]

Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials

Apr 24, 2015

Audience: Pharmacy, Anesthesiology, Veterinary 

ISSUE: Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary).

Risk factors associated with particulate include the potential for particulate to be injected and/or therapy may be delayed. If smaller pieces of the particulate break off and become free floating within the solution, it may be injected into the patient. Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue, in particular in patients allergic or sensitive to iron oxide. In addition, therapy may be delayed if observation of particulate is not made until the point of care. This delay is likely to be of negligible clinical significance provided remediation is readily available.

BACKGROUND: The lot was distributed from July 2014 to September 2014.  Hospira is currently working with its glass supplier and 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. Customers should notify all users in their facility.  Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the user level (both human and veterinary). Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-866-918-8770 between the hours of 8 a.m. to 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:


[04/23/2015 - Press Release - Hospira]

Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates

Apr 22, 2014

Audience: Risk Manager, Pharmacy

[Posted 04/22/2014]

ISSUE: Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. Hospira has attributed the embedded particulate to a supplier’s glass defect.

If the particulate goes undetected and solution is administered, it could block administration of the drug to the patient, causing a delay in therapy. Other risks include local inflammation, mechanical disruption of tissue or immune response to the particulate.

BACKGROUND: Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed December 2013 through January 2014 to wholesalers/distributors, hospitals and clinics nationwide.

Hospira is working with its supplier on implementing corrective and preventive actions.

RECOMMENDATION: Anyone with an 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 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 1-877-546-7642 (M-F, 8 a.m - 5 p.m. ET).

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:

[04/21/2014 - Press Release - Hospira, Inc]
 

Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

Oct 21, 2013

Audience: Health Professional, Risk Manager

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]

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

Nov 13, 2009

Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers

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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