The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1046-2017·Announced 2017-08-09

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 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.

See all 4 products in this recall →

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