D-0469-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 15, 2017
- Initiation Date
- January 18, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17