FDA Recalls Sodium Bicarbonate Injection for Silicone Particulate Contamination
Exela Pharma Sciences recalls 8.4% sodium bicarbonate injection nationwide due to silicone particulate matter in vials. The FDA classified this Class I recall as affecting 355,220 vials.
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 of Severe (4) per the rubric. Silicone particulate contamination in injectable medications represents a serious product-quality defect, though no deaths or reported illnesses are documented in the source.
Plain-English summary
Exela Pharma Sciences LLC is recalling 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL), a prescription intravenous medication. The recall affects 355,220 vials distributed nationwide, including products manufactured for both Exela Pharma Sciences and Civica, Inc.
The FDA initiated this Class I recall due to the presence of silicone particulate matter in the recalled vials. Silicone contamination in injectable medications represents a serious product-quality defect.
Affected lot codes include P0001429 (expires 11/30/2023), P0001900 and P0001902 (expire 08/31/2024), P0001903, P0001909, and P0001945 (expire 09/30/2024), P0002002 (expires 11/30/2024), P0002052 (expires 12/31/2024), and P0001912 (expires 08/31/2024). Healthcare providers and pharmacies should immediately cease use of affected vials and segregate remaining inventory. Affected institutions should contact Exela Pharma Sciences for return instructions and product replacement.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Exela Pharma Sciences LLC
- Category
- Drug — Intravenous Injection
- Hazard
- silicone-particles
- contamination
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 (12)
- a) P0001429
- EXP 11/30/2023 b) P0001900
- P0001902
- EXP 08/31/2024
- P0001903
- P0001909
- P0001945
- EXP 09/30/2024
- P0002002
- EXP 11/30/2024
- P0002052
- EXP 12/31/2024 c) P0001912
Distribution
Distributed nationwide across the United States.
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