{"id":403903,"date":"2023-12-21T07:49:00","date_gmt":"2023-12-21T12:49:00","guid":{"rendered":"https:\/\/platohealth.ai\/fda-alert-hospira-inc-issues-a-voluntary-nationwide-recall-for-4-2-sodium-bicarbonate-injection-8-4-sodium-bicarbonate-injection-and-atropine-sulfate-injection-due-to-the-potential-presence-of-gl\/"},"modified":"2023-12-30T21:24:28","modified_gmt":"2023-12-31T02:24:28","slug":"fda-alert-hospira-inc-issues-a-voluntary-nationwide-recall-for-4-2-sodium-bicarbonate-injection-8-4-sodium-bicarbonate-injection-and-atropine-sulfate-injection-due-to-the-potential-presence-of-gl","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-alert-hospira-inc-issues-a-voluntary-nationwide-recall-for-4-2-sodium-bicarbonate-injection-8-4-sodium-bicarbonate-injection-and-atropine-sulfate-injection-due-to-the-potential-presence-of-gl\/","title":{"rendered":"FDA Alert: Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
December 21, 2023<\/p>\n
Audience: Health Professional, Pharmacy<\/p>\n
December 21, 2023 – NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate<\/a> Injection, USP ABBOJECT\u00ae Glass Syringe, 5 mEq\/10 mL; 8.4% Sodium Bicarbonate Injection, USP Lifeshield\u00ae ABBOJECT\u00ae Glass Syringe, 50 mEq\/50 mL; and Atropine<\/a> Sulfate Injection, USP Lifeshield\u00ae ABBOJECT\u00ae Glass Syringe, 1 mg\/10 mL to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.<\/p>\n Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events. 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.<\/p>\n 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.<\/p>\n To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.<\/p>\n 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.<\/p>\n Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by intravenous injection and is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.<\/p>\n The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers\/hospitals\/institutions in the United States and Puerto Rico from March 14, 2023 through June 29, 2023.<\/p>\n