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…
- FDA Drug
- Class II
- terminated
- Published 2017-02-15
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-0469-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-18 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | 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 |
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_info | Lot #'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
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