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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- VistaPharm, Inc.
- Reason for Recall:
- Defective Container: Leakage of unit dose cups that may occur at the seal.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0469-2017
Related Recalls
Failed Excipient Specifications: high content of ethylene glycol (EG)
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.