Drug product
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.
D-0469-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75640
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,609 cases
- Official record key
drug-enforcement:D-0469-2017
Official wording
Reason: Defective Container: Leakage of unit dose cups that may occur at the seal.
Code information: Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
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.
Derived failure modes
-
Unknown
Defective Container: Leakage of unit dose cups that may occur at the seal.