August 2017 FDA Recall Drug by Vistapharm, Inc.
D-1139-2017 - Labeling

This Class III drug recall was voluntarily initiated by Vistapharm, Inc. on August 17, 2017 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-1139-2017

Reason for Recall
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Initiated
08-17-2017
Reported
09-20-2017
Quantity
3084 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77998
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.
03-11-2019
Product Description About Product Description
Full technical description of the product.
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

Batch or Lot Expiration Information

Lot# Lot: 494700 Exp. 10/2018