Safety Alerts & Recalls

What does this mean?

This recall for ProAir HFA (albuterol sulfate), Inhalation Aerosol, 90 mcg from Teva Pharmaceuticals was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. However, this alert is a good reminder that you should regularly check the expiration date on your ProAir HFA or other brand of albuterol inhaler (Proventil HFA ot Ventolin HFA) and have it refilled if your current supply is beyond its expiration date. If you use ProAir HFA or another albuterol product and have any concerns, you should speak to your doctor or pharmacist.

Teva Pharmaceuticals Inc. Recalls Several Lots of ProAir HFA

Teva Pharmaceuticals has recalled several lots of ProAir HFA (albuterol sulfate), Inhalation Aerosol, 90 mcg. The following lot numbers are being recalled because these lots failed the manufacturer's tests to ensure they had identical contents: AEC57A, AEC59A, AEC75A, and AEC84A. Three of the lots (AEC57A, AEC59A, AEC75A) have expired and lot number AEC84A expires this month (January 2011).

ProAir HFA contains the active ingredient albuterol sulfate and is commonly used in the treatment of asthma. Albuterol sulfate is also sold under other formulations brand names. This recall alert only applies to the select lots of ProAir HFA (albuterol sulfate), Inhalation Aerosol, 90 mcg. No other albuterol products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2011-01-10
Last Updated: 2011-01-11

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