Why it was recalled
Defective Container: Leakage of unit dose cups that may occur at the seal.
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.
Lot numbers, UPCs & expiration codes
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Where it was 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 to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0469-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 18, 2017
- FDA report date
- Feb 15, 2017
- Quantity
- 13,609 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0469-2017, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 75640
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
- Postal code
- 33771-4809
- Report date
- Feb 15, 2017
- Product type
- Drugs
- Recall number
- D-0469-2017
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 13,609 cases
- Reason for recall
- Defective Container: Leakage of unit dose cups that may occur at the seal.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- 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.
- Recall initiation date
- Jan 18, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2017