FDA Recalls Sodium Bicarbonate Injection Due to Glass Particle Contamination
Pfizer Inc. is recalling 21,200 cartons of Sodium Bicarbonate Injection (lot HA7295, expiring March 1, 2025) nationwide due to glass particle contamination. The product is distributed in the United States and Puerto Rico.
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 recall. While no illnesses or injuries have been reported, the agency's Class I classification indicates a serious hazard and mandates a minimum severity of 4 per the rubric.
Plain-English summary
Pfizer Inc., through its Hospira subsidiary, is recalling Sodium Bicarbonate Injection, USP 8.4% (50 mEq/50 mL) supplied in Lifeshield glass syringes due to the presence of glass particles. This is a Class I FDA recall.
The affected product is identified by lot HA7295 with an expiration date of March 1, 2025. The product NDCs are 0409-6637-24 (carton) and 0409-6637-14 (case).
Approximately 21,200 cartons of the affected lot were distributed nationwide in the United States and Puerto Rico.
The recalled product
- Product
- SODIUM BICARBONATE (SODIUM BICARBONATE)
- Brand
- SODIUM BICARBONATE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Parenteral / Intravenous
- Affected units
- 21,200
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 (2)
- Lot HA7295
- EXP 03/01/2025
Distribution
Part of a larger recall action
This product is one of 3 recalled by Pfizer Inc. 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 3 products in this recall →Related recalls
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