Hospira, Inc., Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate, 1% and 2% Lidocaine HCl Injections, USP

Hospira, Inc., a Pfizer company, said that patients who receive an injectable product containing glass particulate matter have an unlikely probability for serious adverse events, including death. Potential complications include thrombophlebitis, granuloma, and blockage of blood vessels or life-threatening blood clot events. Frequency and severity of adverse events could vary depending upon factors such as size and number of particles in the drug product, patient comorbidities (e.g., age, compromised organ function), and presence or absence of vascular anomalies. The label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration, which may reduce risk.

To date, Hospira, Inc., said that it has not received reports of any adverse events associated with the issue for the affected lots.

Sodium bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO₃) in water for injection for IV administration as an electrolyte replenisher and systemic alkalizer. It is indicated for the treatment of metabolic acidosis, which may occur with severe renal disease, uncontrolled diabetes, circulatory insufficiency from shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest, and severe primary lactic acidosis. Sodium bicarbonate is also indicated for 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 urine alkalinization to diminish nephrotoxicity of hemoglobin and its breakdown products. It is also indicated for 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 via IV with either direct injection or continuous infusion or intramuscularly. It is available in various concentrations 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.

The affected products were distributed nationwide to wholesalers, hospitals, and institutions in the United States and Puerto Rico from October 13–26, 2022.The national drug codes (NDCs), lot numbers, expiration dates, and configuration details are listed below.

Product	NDC	Lot Number	Expiration Date	Presentation	Configuration and Count
4.2% sodium bicarbonate injection, USP, glass Abboject® syringe	Carton: 0409-5534-24 Case: 0409-5534-14	GJ5007	1AUG2024	5 mEq/10 ml (0.5 mEq/ml)	1 vial and injector per carton, 10 cartons per bundle, case pack 5 x 10- 10 ml
1% lidocaine HCl injection, USP, Lifeshield® glass Abboject® syringe	Carton: 0409-4904-11 Case 0409-4904-34	42290DK	1JUN2024	50 mg/5 ml (10 mg/ml)	1 vial and injector per carton, 10 cartons per bundle, case pack 5 x 10- 5 ml
2% lidocaine HCl injection, USP, Lifeshield® glass Abboject® syringe	Carton: 0409-4903-11 Case: 0409-4903-34	GH6567	1JUL2024	100 mg/5 ml (20 mg/ml)	1 vial and injector per carton, 10 cartons per bundle, case pack 5 x 10- 5 ml

Hospira, Inc., said that Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product.

Wholesalers, hospitals, institutions, and practices with an existing inventory of a recalled lot should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations that may have received the recalled product. Hospitals and institutions should inform healthcare professionals in their organization of the recall. For additional assistance, call Sedgwick Inc. at 800-805-3093 from 8 am–5 pm ET, Monday–Friday.

Healthcare professionals with questions regarding this recall can contact Pfizer Medical Information or Drug Safety:

• For medical questions regarding the product, contact Pfizer Medical Information at 800-438-1985, option 3, from 8 am–7 pm ET, Monday–Friday.                 
• To report adverse events and product complaints, contact Pfizer Drug Safety at 800-438-1985, option 1, 24 hours a day, 7 days a week.

Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.