Potassium Chloride For Injection Concentrate syringe 40 mEq/ recalled over manufacturing violations

Recall date

July 3, 2018

Source

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

Official notice title

Medi-Fare Drug and Home Health Center recalls Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Co…

Recall number

D-0919-2018

FDA classification

Class II

Brand / firm

Medi-Fare Drug and Home Health Center

Sold / distributed

Texas only

Why it was recalled

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

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 Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007