August 2014 FDA Recall Drug by Vistapharm, Inc.
D-0010-2015 - Defective Container
This Class II drug recall was voluntarily initiated by Vistapharm, Inc. on August 13, 2014 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0010-2015
Defective Container: Product leaks when inverted.
08-13-2014
10-15-2014
322,650 Cups
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide, including Puerto Rico
02-24-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), 10 mL cups, Rx only. Manufactured by VistaPharm Inc., Largo, FL 33771. NDC 66689-031-01.
Batch or Lot Expiration Information
Lot# : 283700, Expiry: 11/14
Lot# : 291400, Expiry: 01/15; and
Lot# : 303500, Expiry: 04/15.
