Recalls / Class II
Class IID-0469-2017
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.
- Affected lot / code info
- Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17
Why it was recalled
Defective Container: Leakage of unit dose cups that may occur at the seal.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 13,609 cases
- 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.
Timeline
- Recall initiated
- 2017-01-18
- FDA classified
- 2017-02-06
- Posted by FDA
- 2017-02-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0469-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.