RecallRadar

FDA Drug recall D-0997-2017

Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only

On 2017-07-26 the FDA classified a Class II recall of Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only by Pharmedium Services, citing lack of Assurance of Sterility; media fill failure at manufacturer.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0997-2017
ClassificationClass II
Statusterminated
Initiated2017-06-26
Published2017-07-26
Last updated2026-09-13 11:51 UTC
CompanyPharmedium Services
DistributionUS

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

Lack of Assurance of Sterility; media fill failure at manufacturer

Identifiers

code_infoLot: 171420030D, 8/21/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0997-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.