Thea Pharma Inc. ("Thea") is responding to the recent statement related to the Akorn Operating Company LLC ("Akorn") voluntary nationwide recall.
On April 26, 2023, the Akorn Trustee issued a company announcement that initiated a voluntary recall of various within-expiry human and animal products as a result of its U.S. facility closures and discontinuation of the Quality activities of these marketed products.
Akorn's recall announcement has raised questions related to the Thea portfolio of products, AcellFX, Akten, AzaSite, Betimol, Cosopt, Cosopt PF, and Zioptan acquired last year from Akorn.
These Thea products are not impacted by Akorn's recall. None of these products are manufactured at Akorn's U.S. facilities that have been closed.
For your reference, the Thea portfolio of products is described in the table below. Note that the Akorn and new Thea labeled versions of these products are equivalent and are both unaffected by the Akorn voluntary recall.
Thea Product Descriptions
- Akten(lidocaine hydrochloride ophthalmic gel) 3.5%
- AzaSite (azithromycin ophthalmic solution) 1% sterile
ophthalmic drops - Betimol (timolol ophthalmic solution) 0.25%, 0.5%
- Cosopt (dorzolamide hydrochloride-timolol maleate
ophthalmic solution) - Cosopt PF (dorzolamide hydrochloride-timolol maleate
ophthalmic solution) - Zioptan (tafluprost ophthalmic solution) 0.0015%