CLASS II Drug recall · Reported 15 Feb 2017 · FDA Enforcement Report
Potassium Chloride Oral Solution, USP, 10%, 20 mEq recalled
VistaPharm is recalling Potassium Chloride Oral Solution, USP, 10%, 20 mEq per, distributed in 36 states. The recall was initiated on 18 Jan 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0469-2017
- FDA event ID
- 75640
- Recalling firm
- VistaPharm, Largo, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2017
- FDA classified
- 6 Feb 2017
- Reported
- 15 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Jan 2017 | Recall initiated by company | |
| 6 Feb 2017 | Classified by FDA | +19 days |
| 15 Feb 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Leakage of unit dose cups that may occur at the seal.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
Defective Container: Leakage of unit dose cups that may occur at the seal.
Which lots are affected?
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Where was it sold?
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.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from VistaPharm
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalled | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalledPyridostigmine Bromide | VistaPharm | Potency & Assay | Nationwide |
Other Potassium Chloride recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in flexible container recalledPotassium Chloride | ICU Medical | Labeling Errors | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total recalled by ICU MedicalPotassium Chloride | ICU Medical | Other | Nationwide |
| Drug | CLASS II | Potassium Chloride Extended-Release Tablets, USP, 10 mEq recalledPotassium Chloride | The Harvard Drug Group | Potency & Assay | Nationwide |