RecallRadar

FDA Drug recall D-0469-2017

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 ca…

On 2017-02-15 the FDA classified a Class II recall of 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 ca… by Vistapharm, citing defective Container: Leakage of unit dose cups that may occur at the seal.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0469-2017
ClassificationClass II
Statusterminated
Initiated2017-01-18
Published2017-02-15
Last updated2026-09-13 11:51 UTC
CompanyVistapharm
DistributionAL, 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

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

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

Identifiers

code_infoLot #'s: 437600, Exp 07/17; 447100, Exp 10/17

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0469-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.