Sodium Bicarbonate Injection Recalled for Defective Vials with Glass Breakage Risk
Exela Pharma Sciences is recalling 2,123,040 vials of Sodium Bicarbonate 8.4% Injection due to container defects causing vial breakage and glass release when pressurized during product 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: The FDA classified this as a Class I recall. According to the severity rubric, FDA Class I recalls must score at least 4. The specific hazard is container defect leading to glass breakage and projectiles during product preparation. Without reported fatalities, the classification is Severe (4) rather than Critical (5).
Plain-English summary
Exela Pharma Sciences LLC is recalling 2,123,040 vials of Sodium Bicarbonate 8.4% Injection USP (50 mEq/50 mL single-dose vials), distributed nationwide. The FDA has classified this as a Class I recall.
The reason for the recall is defective container vials. The manufacturer has received complaints that vials break and release glass when pressurized during product preparation for administration.
The affected vials span multiple lot numbers with expiration dates from October 2023 through May 2024.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Injectable / Intravenous
- Hazard
- glass-breakage
- sharp-object-injury
- 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 (20)
- Lot # : P0001370
- P0001371
- P0001372
- Exp. 10/2023
- P0001433
- P0001434 Exp. 11/2023
- P0001443
- P0001468
- P0001469
- P0001470
- P0001495
- P0001505
- P0001506
- P0001509
- P0001510
- P0001511
- P0001512 Exp. 12/2023
- P0001560
- P0001561
- P0001562
Distribution
Distributed nationwide across the United States.
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