Safety Alerts & Recalls

What does this mean?

This recall for Azelastine Hydrochloride Ophthalmic Solution, 0.05% from Sun Pharmaceutical Industries 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. If you use Azelastine Hydrochloride Ophthalmic Solution, 0.05% and are concerned, you should speak to your doctor.

Sun Pharmaceutical Industries Recalls Several Lots of Azelastine Hydrochloride Ophthalmic Solution, 0.05%

Sun Pharmaceutical Industries has recalled several lots of Azelastine Hydrochloride Ophthalmic Solution, 0.05%. The following lot numbers have been recalled because samples from these lots did not pass the manufacturer's routine tests for impurities and by-products from chemical breakdown over time: JKJl389A, JKJ1514A JKJ1515A. JKJ2541A, JKJ2542A, JKJ2646A, JKJ3050A, JKJ3425A, JKJ3126A, JKK0817A, JKK0884A, JKK0885A, JKJ2187A, JKK2268A, JKK2269A, JKK2315A, JKK2472A, and JKK2473A.

Azelastine is used in the treatment of allergic eye symptoms. Azelastine is also sold under the brand name Optivar and is also available as a nasal spray. No other lots, strengths, or brands of Azelastine were involved in this recall.

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

Source: FDA
Publication Date: 2012-03-07
Last Updated: 2012-03-09

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