Exela Pharma Sciences recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL, nationwide in the U.S. The recall cites out-of-spec arsenic impurities. Consumers should stop use and contact a healthcare provider. Follow recall notice for guidance and refunds.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Consumers and healthcare providers should stop using this product immediately. Contact Exela Pharma Sciences LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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IV sodium bicarbonate injection used to treat acid-base disorders and metabolic acidosis in hospitalized patients.
Arsenic impurities in impurities tested may pose serious safety risks if administered intravenously.
This recall is not clearly described as part of a broader industry pattern.
Immediate discontinuation advised. Potential safety risk to patients receiving IV treatment.
FDA enforcement report linked in recall notice for full scope.
Consumers should expect recall communications and guidance to be issued within days; replacement or refund processes follow company notification.
Keep copy of recall notification, NDCs, lot number, expiration date, and correspondence with manufacturer.
Product: 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL). Form: 10 mL single-dose vial. Type: Intravenous use only. Rx only. Manufactured and distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA. NDC: 51754-5012-1 (vial); 51754-5012-4 (carton). Sold nationwide in the USA. Lot: 10004077. Expiration: 02/28/2026.
No specific patient injury or incident counts are provided in the notice. The status remains ACTIVE and classified as HIGH hazard.
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