Potassium Chloride Oral Solution — Class II drug recall D-0469-2017
Terminated recall by VistaPharm, Inc., reported 2017-02-15, distributed in AL, AZ, CA, CO, CT, FL, GA, HI…. Defective Container: Leakage of unit dose cups that may occur at the seal.
| Recall number | D-0469-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2017-01-18 |
| Classified | 2017-02-06 |
| Reported by FDA | 2017-02-15 |
| Distributed | 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 |
| Quantity | 13,609 cases |
| Reason classes | packaging |
| NDC | 66689-0047-01, 66689-0047-50 |
| Lot numbers | 07/17, 10/17, 437600, 447100 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0469-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.