January 2011 FDA Recall Drug by Vistapharm, Inc.
D-1669-2012 - Labeling

This Class III drug recall was voluntarily initiated by Vistapharm, Inc. on January 19, 2011 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1669-2012

Reason for Recall
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Initiated
01-19-2011
Reported
09-05-2012
Quantity
73,800 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62887
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
VistaPharm, Inc.
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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-30-2012
Product Description About Product Description
Full technical description of the product.
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771

Batch or Lot Expiration Information

Lot# 195900 exp. 01/12.