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.
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 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
- Hazard
- glass-contamination
- injection-hazard
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
Distributed nationwide across the United States.
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