The Recall Desk
SevereFDA (Drugs)·D-0865-2016·Announced 2016-06-01

Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter

Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.

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 agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Hospira Inc. is voluntarily recalling 72,000 units of 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only. The recall was initiated after particulate matter, identified as an insect, was discovered in one vial of the product.

The affected product is identified by Lot # 56-148-EV with an expiration date of 8/1/2017. The NDC number is 0409-6625-02. The recall covers units distributed nationwide.

Healthcare providers and patients should stop using the affected product and contact Hospira Inc. for further instructions or replacement. This recall is classified as Class I by the FDA.

The recalled product

Product
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Manufacturer
Hospira Inc.
Affected units
72,000

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 # 56-148-EV
  • Exp 8/1/2017

Distribution

Distributed nationwide across the United States.