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Recall Observatory FDA recall evidence

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

January 18, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    Defective Container: Leakage of unit dose cups that may occur at the seal.