August 2012 FDA Recall Drug by Dispensing Solutions, Inc
D-1691-2012 - Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol

This Class II drug recall was voluntarily initiated by Dispensing Solutions, Inc on August 28, 2012 for the product Drug. The FDA reported the reason for recall as label mix up; side panel of sticker label applied by dispensing solutions inc. incorrectly indicates product name as ventolin hfa 90 mcg instead of correctly as atrovent hfa 12.9 grams inhalation aerosol. The product was distributed in US: IN & WI and the recall is currently terminated.

Recall Number: D-1691-2012

Reason for Recall
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Initiated
08-28-2012
Reported
10-03-2012
Quantity
18 Inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63095
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.
Dispensing Solutions, 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.
US: IN & WI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-01-2012
Product Description About Product Description
Full technical description of the product.
Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947

Batch or Lot Expiration Information

Lot# F23989, F22311