FDA Drug Moderate Class II Terminated

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

Reported: August 9, 2017 Initiated: June 15, 2017 #D-1046-2017

Product Description

Reason for Recall

Lack of Sterility Assurance

Details

Recalling Firm: Hospira a Pfizer Company
Units Affected: 20,337,650 15 mL single dose vials
Distribution: U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore
Location: Rocky Mount, NC

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by Hospira a Pfizer Company. Units affected: 20,337,650 15 mL single dose vials.

Why was this product recalled? ▼

Lack of Sterility Assurance

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1046-2017.