Hospira, Inc., owned by drug major Pfizer Inc., is recalling certain Sodium Bicarbonate and Lidocaine HCl Injections citing the potential for presence of glass particulate matter, the U.S. Food and Drug Administration said.
The recall involves 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.
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis that 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 and in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Lidocaine Hydrochloride Injection, USP 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 recalled products were distributed to wholesalers/hospitals/institutions in the United States and Puerto Rico from October 13, 2022 through October 26, 2022.
The recall was initiated due to the potential for presence of glass particulate matter. An injection of visible and subvisible inert particles could cause inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events.
The agency noted that there is an unlikely probability for serious adverse events, including death, if a patient receive an injectable product found to contain particulate matter identified as glass.
However, Hospira has not received reports of any adverse events related to the recalled products to date.
Wholesalers, hospitals, institutions, and doctors with an existing inventory of an affected lot are urged to discontinue use, stop distribution and quarantine the product immediately.
In similar recalls, Merck Animal Health, affiliated to drug major Merck & Co., Inc., in early September recalled three batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States citing the presence of particulate matter.
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