Event ID |
75640 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-0469-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
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. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
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. What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
13,609 cases Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
Report Date |
02-15-2017 |
Recall Initiation Date |
01-18-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall. |
Product Type |
Drugs |
Recalling Firm |
VistaPharm, Inc. |
Code Info |
Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
Recalled NDC Packages |
66689-047-01; 66689-047-50; 66689-047-99; 66689-047-30; 66689-047-80; 66689-048-01; 66689-048-80; 66689-048-30; 66689-048-99; 66689-048-50 |
Status |
Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
|
View Recall Report |