The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0079-2023·Announced 2022-12-21

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units
489,600

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.

Part of a larger recall action

This product is one of 2 recalled by Exela Pharma Sciences LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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