July 2018 FDA Recall Drug by Medi-fare Drug And Home Health Center
D-0919-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Medi-fare Drug And Home Health Center on July 3, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Texas only and the recall is currently terminated.

Recall Number: D-0919-2018

Reason for Recall
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Initiated
07-03-2018
Reported
07-18-2018
Quantity
1116 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80453
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Medi-Fare Drug and Home Health Center
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Texas only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-03-2019
Product Description About Product Description
Full technical description of the product.
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007

Batch or Lot Expiration Information

Lot# Lot: 20180522@1 Exp.: 08/20/18