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Recall of Albuterol Sulfate Inhalation Solution, 0.083%

Oct 17, 2013 12:35PM ● By Cate Reynolds
We received the information below on Thursday, October 17, 2013, from the U.S. Food and Drug Administration (FDA). What exactly does it mean? Well, it’s an announcement of a voluntary recall of a very commonly prescribed medication for asthma, allergies, COPD and other ailments. This voluntary recall was issued by the manufacturer, not the FDA—the FDA is just letting us know about it. We spoke to a local pharmacist to try and understand what the problem with the medication was, since the press release is a little vague. According to the pharmacist (who did not want to be named), internal testing at the company caught some minor contamination in a small batch of the albuterol inhalers (“Some dirt got into it,” the pharmacist said). He also said that the internal testing at a company like this is usually much stricter than that of the FDA and can be relied upon for thoroughness.
Sarah Hagerty, Health & Special Projects Editor, What’s Up Media


Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Nephron Pharmaceuticals Corporation Announces Voluntary Recall of Albuterol Sulfate Inhalation Solution, 0.083%

1-800-443-4313 ext. 2292

FOR IMMEDIATE RELEASE- October 10, 2013- Nephron Pharmaceuticals Corporation (NPC) has initiated a voluntary recall, at the retail level, as a precautionary measure, due to results from our internal monitoring processes. NPC is asking retailers to remove the affected lots from store shelves and is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. This voluntary recall will affect the following product:

Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25)

Ten (10) lots have been identified as impacted by this recall:

A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A

NPC performs aseptic process simulation as part of our internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, in accordance with published guidance regarding aseptic processing simulation from the Food and Drug Administration (FDA), NPC has decided to initiate this recall as a precautionary measure.

No other NPC products or lots are impacted by this recall.

We are ready to work with every affected customer to ensure that the recall is not disruptive for the supply of this important drug product.