FDA-Drug2017-02-15Class II
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.
VistaPharm, Inc.
Hazard
Defective Container: Leakage of unit dose cups that may occur at the seal.
Sold states
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.
Affected count
13,609 cases
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
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 VistaPharm, Largo, FL 33771.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0469-2017Don't want to check this manually?
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