FDA Recalls Sodium Bicarbonate Injection for Defective Vials
Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric, indicating potential for serious adverse health consequences. No illnesses or injuries have been reported, but the agency's determination that this represents serious risk warrants a Severe rating.
Plain-English summary
Exela Pharma Sciences LLC is recalling 489,600 vials of 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL single-dose vials) nationwide. The recall is due to complaints received regarding vial breakage and glass flying when the vials are pressurized while being prepared for administration.
The product recalled consists of 50 mL single-dose vials supplied in cartons of 20. Affected lot numbers include P0001178, P0001298, P0001301, P0001313, P0001314, P0001317, P0001330, P0001464, P0001442, P0001467, P0001472, P0001486, and P0001532, with expiration dates ranging from May 2023 to December 2023.
This FDA Class I recall indicates that the defective vials pose a potential for serious adverse health consequences. The risk stems from glass fragments that can result from vial breakage during pressurization, creating a hazard when the product is prepared for intravenous injection.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Injectable
- Hazard
- glass-breakage
- glass-fragments
- container-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lots: P0001178 Exp. 05/2023
- P0001298
- P0001301
- P0001313
- P0001314
- P0001317 Exp. 08/2023
- P0001330
- P0001464 Exp. 09/2023
- P0001442 Exp. 11/2023
- P0001467
- P0001472
- P0001486
- P0001532 Exp. 12/2023.
Distribution
Distributed nationwide across the United States.
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