FDA recall D-0991-2017

Product

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48

Reason for recall

Lack of Assurance of Sterility; media fill failure at manufacturer

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-06-26

Report date

2017-07-26

Termination date

2020-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2017