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D-1046-2017 Class II Terminated

Recalled by Hospira a Pfizer Company — Rocky Mount, NC

FDA drug recall D-1046-2017 was initiated by Hospira a Pfizer Company on June 15, 2017 and is designated Class II. Reason for recall: Lack of Sterility Assurance The recall status is terminated (terminated July 20, 2020). Affected quantity: 20,337,650 15 mL single dose vials.

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