June 2015 FDA Recall Drug by Vistapharm, Inc.
D-1831-2015 - Defective Container

This Class III drug recall was voluntarily initiated by Vistapharm, Inc. on June 26, 2015 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in U.S. Including: CA, IL, LA, OH, PA, and SC. and the recall is currently terminated.

Recall Number: D-1831-2015

Reason for Recall
Defective Container: Lids on unit dose cups are not fully qualified.
Initiated
06-26-2015
Reported
10-07-2015
Quantity
84,100 Cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71601
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Including: CA, IL, LA, OH, PA, and SC.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2017
Product Description About Product Description
Full technical description of the product.
METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.

Batch or Lot Expiration Information

Lot# : 387500, Expiry: 01/17