D-1046-2017 Class II Terminated

Recalled by Hospira a Pfizer Company — Rocky Mount, NC

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
June 15, 2017
Termination Date
July 20, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20,337,650 15 mL single dose vials

Product Description

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

Reason for Recall

Lack of Sterility Assurance

Distribution Pattern

U.S. (including Puerto Rico), Dutch Antilles, Barbados, Canada, Philippines, Kuwait, and Singapore

Code Information

Lot: 74119EV Exp. 02/01/2019 Lot: 74120EV Exp. 02/01/2019 Lot: 74121EV Exp. 02/01/2019 Lot: 74307EV Exp. 02/01/2019 Lot: 75326EV Exp. 03/01/2019 Lot: 75327EV Exp. 03/01/2019 Lot: 75215EV Exp. 03/01/2019