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.

FDA recall notice · announced February 15, 2017 · Vistapharm

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

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

Notes

Distribution: Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.
Lot/code information: Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Quantity: 13,609 cases
Status: Terminated
Products in this recall event:
- 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 Vi (D-0469-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.