FDA recall D-0996-2017

Product

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

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-0996-2017