Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (...
FDA Drug Recall #D-0469-2017 — Class II — January 18, 2017
Recall Summary
| Recall Number | D-0469-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 18, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | VistaPharm, Inc. |
| Location | Largo, FL |
| Product Type | Drugs |
| Quantity | 13,609 cases |
Product Description
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.
Distribution Pattern
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.
Lot / Code Information
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Other Recalls from VistaPharm, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0018-2023 | Class II | Pyridostigmine Bromide Oral Solution, USP 60 mg... | Sep 30, 2022 |
| D-0376-2022 | Class II | Clobazam Oral Suspension 2.5 mg/mL, 120 mL bott... | Jan 7, 2022 |
| D-0019-2021 | Class III | NYSTATIN ORAL SUSPENSION, USP 100,000 units per... | Sep 25, 2020 |
| D-1378-2020 | Class III | Nystatin Oral Suspension, USP 100,000 units per... | Jun 23, 2020 |
| D-1377-2020 | Class III | Nystatin Oral Suspension, USP 500,000 units/5mL... | Jun 23, 2020 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.