FDA recall D-1691-2012

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

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

Distribution

US: IN & WI

Key facts

Status

Terminated

Initiation date

2012-08-28

Report date

2012-10-03

Termination date

2012-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Ana, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1691-2012