Hospira Recalls Potassium Phosphates Injection Due to Sterility Concerns
Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.
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 II. Per the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the 'Lack of Sterility Assurance' for an injectable drug represents a significant risk of serious harm, aligning with the Severe criteria for Class II recalls with potential for significant injury.
Plain-English summary
Hospira, a Pfizer Company, is recalling 20,337,650 single-dose vials of Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL). The recall is being conducted due to a lack of sterility assurance. The affected product is a prescription-only medication that must be diluted before use.
The recall covers specific lots with expiration dates of February 1, 2019, and March 1, 2019. The product was distributed in the United States (including Puerto Rico), the Dutch Antilles, Barbados, Canada, the Philippines, Kuwait, and Singapore.
Healthcare providers and patients should discontinue use of the affected lots and contact Hospira for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
- Manufacturer
- Hospira a Pfizer Company
- Category
- Drug — Injectable
- Hazard
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Hospira a Pfizer Company 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.
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