Drug recall: Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 un

FDA enforcement event 75640 · Class II · initiated 18 Jan 2017 · status Terminated

DrugVoluntary: Firm initiated1 product recordLargo, FL

FDA enforcement event 75640 is a drug recall by VistaPharm, Inc. of Largo, FL, initiated 18 Jan 2017 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated. Initiation: voluntary: firm initiated. VistaPharm, Inc. has 20 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

VistaPharm, Inc., Largo, FL.

Reason for recall

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

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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
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 case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.	13,609 cases	Class II	Terminated	15 Feb 2017

Context

57%of 2017 drug events are Class II343 events that year

1product record in this eventfirm median: 1

20events on this register for the firm

Other enforcement events for VistaPharm, Inc.

Initiated	Product (first record)	Type	Class	Records
30 Sep 2022	Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: Vi	Drug	Class II	1
7 Jan 2022	Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 6668	Drug	Class II	1
25 Sep 2020	NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) M	Drug	Class III	1
23 Jun 2020	Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 3377	Drug	Class III	2
30 Nov 2018	NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose	Drug	Class III	1
17 Aug 2017	Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx onl	Drug	Class III	1
26 Jun 2017	Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by Vi	Drug	Class II	2
17 May 2017	Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000	Drug	Class III	1
18 Jan 2017	Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16	Drug	Class II	11
9 Nov 2016	Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per	Drug	Class II	1

All 20 events for VistaPharm, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Defective Container: Leakage of unit dose cups that may occur at the seal."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Terminated. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.