Potassium PHOSphate in 0 recalled over sterility concerns

Recall date

June 26, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

PharMedium Services, Llc recalls Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 N…

Recall number

D-0987-2017

FDA classification

Class II

Brand / firm

PharMedium Services, Llc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility; media fill failure at manufacturer

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749