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.
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: 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.
- Category
- Drug — Injectable
- 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.
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