FDA recall D-1046-2017

Hospira a Pfizer Company · Class II · drug

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

Reason for recall

Lack of Sterility Assurance

Distribution

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

Key facts

Status: Terminated
Initiation date: 2017-06-15
Report date: 2017-08-09
Termination date: 2020-07-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rocky Mount, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1046-2017