The Recall Desk
SevereFDA (Drugs)·D-0234-2024·Announced 2024-01-24

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.
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.