Albuterol Inhaler (Ventolin HFA)
January 24, 2012
GlaxoSmithKline has voluntarily recalled several lots of albuterol inhaler (Ventolin HFA). Some canisters may contain insufficient propellant to deliver the labeled number of 60 doses. If the affected canisters are used, patients may need additional treatment of bronchospasm symptoms, such as wheezing, chest tightness, or shortness of breath. The affected canisters were distributed in the United States (US) and Puerto Rico between September 23, 2011 and January 10, 2012. The following products are affected:
- Ventolin HFA inhaler, NDC 0173-0682-21: lot number 1ZP0922
- Ventolin HFA inhaler sample, NDC 0173-0682-23: lot numbers 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, and 1ZP8151
- Ventolin HFA inhaler institutional pack, NDC 0173-0682-24: lot numbers 1ZP0856, 1ZP1981, 1ZP6941, 1ZP7824, and 1XP9063
- Ventolin HFA Novaplus, NDC 0173-0682-54: lot numbers 1ZP1061, 1ZP6940, and 1ZP9680.
GlaxoSmithKline advises that healthcare facilities not use these products. Quarantine and return all affected products. Directions for product returns differ between Puerto Rico and the rest of the US:
- Customers in Puerto Rico: Contact GlaxoSmithKline Puerto Rico Customer Service at 787-774-1600 (extensions 4991, 4990, or 2068) for return instructions.
- Customers throughout the rest of the US: Customers may contact Stericycle at 888-548-8521 for shipping assistance.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm). Additional information is available at the following links:
- GlaxoSmithKline Recall Notice:
- GlaxoSmithKline Puerto Rico Recall Notice: PDF attached
January 24, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.