FDA recall D-0997-2017

Product

Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11

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-0997-2017