FDA recall D-0913-2017

Product

Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

Reason for recall

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-02-17

Report date

2017-06-21

Termination date

2017-06-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0913-2017