Safety Alerts & Recalls

What does this mean?

This recall for Hydrocortisone and Acetic Acid and Acetasol HC Otic Solution sold in 10 mL bottles from Actavis Mid Atlantic LLC was issued at a warehouse/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. If you use Hydrocortisone and Acetic Acid or Acetasol HC Otic Solution and are concerned, you should talk to your doctor or pharmacist.

Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products

Actavis Mid Atlantic LLC is recalling a select lots of the ear infection medicine Hydrocortisone and Acetic Acid and Acetasol HC Otic Solution sold in 10 mL bottles. The following lot numbers are being recalled because samples from these lots failed the routine stability tests performed by the manufacturer: 1) Acetasol HC (Hydrocortisone and Acetic Acid) Otic Solution in 10 mL bottles - Lot numbers: L904031, L905006, L906005, L908096, and L911011

2) Hydrocortisone and Acetic Acid Otic Solution in 10 mL bottles - Lot numbers: L906074, L907008, L908096, and L911011

Hydrocortisone and Acetic Acid Otic solution is used in the treatment of ear infections and is also sold under several brand names including Acetasol HC and Vosol HC. This recall alert only applies to the select lots of Acetasol HC and Hydrocortisone and Acetic Acid Otic solution made by Actavis Mid Atlantic LLC. No other Hydrocortisone and Acetic Acid products were involved in this recall.

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

Source: FDA
Publication Date: 2010-06-07
Last Updated: 2010-06-07

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