FDA Drug Class II — Moderate

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

Hazard

Defective Container: Leakage of unit dose cups that may occur at the seal.

Products

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by V
Brand
VistaPharm, Inc.
UPC
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17

Units Affected

13,609 cases