United States
Hospira, Inc., a Pfizer company, is voluntarily recalling 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level due to the potential presence of glass particulate matter. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The products were distributed nationwide to wholesalers/hospitals/institutions in the United States and Puerto Rico from October 13, 2022 through October 26, 2022.
The recalled products are:
- 4.2% Sodium Bicarbonate Injection, USP Glass ABBOJECT® Syringe, NDC: Carton 0409-5534-24. Case: 0409-5534-14. Lot: GJ5007. Expiration Date: 1AUG2024. Presentation: 5 mEq/10mL, (0.5 mEq/mL) Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 10mL
- 1% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe. NDC: Carton 0409-4904-11 Case 0409-4904-34. Lot: 42290DK. Expiration Date: 1JUN2024. Presentation: 50 mg/5mL (10 mg/mL). Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL
- 2% Lidocaine HCl Injection, USP LIFESHIELD® Glass ABBOJECT® Syringe. NDC: Carton 0409-4903-11 Case 0409-4903-34. Lot: GH6567. ExpirationDate: 1JUL2024. Presentation: 100 mg/5mL (20 mg/mL). Configuration/ Count: 1 vial and injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL
There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO3) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. It is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of an antiarrhythmic agent administered intravenously by either direct injection or continuous infusion. It is available in various concentrations. It is administered intravenously or intramuscularly and is specifically indicated in the acute management of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.
Wholesalers, hospitals, institutions, and doctors with an existing inventory of a lot which is being recalled should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.
Company name: Hospira, Inc.
Brand name: Hospira
Product recalled: 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP
Reason of the recall: Potential Presence of Glass Particulates
FDA Recall date: October 02, 2023
Source:
www.fda.gov
