FDA notification regarding tetracaine ophthalmic solution 0.5%
FDA requested companies stop distributing unapproved versions of tetracaine ophthalmic solution 0.5%.
The agency approved Alcon Laboratories Inc.’s tetracaine hydrochloride ophthalmic solution 0.5% STERI-UNIT (NDC 0065-0741) on February 29, 2016, and Bausch Health Ireland Limited’s tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml bottle (NDC 42702-170 and 68682-920) on March 12, 2019. All other tetracaine hydrochloride ophthalmic solution 0.5% products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:
| Drug NDC | Product name |
|---|---|
| 59390-181 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 54799-504 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 54799-505 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 24208-920 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 66267-924 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 68071-4579 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 68788-0920 | Tetracaine hydrochloride ophthalmic solution 0.5%, 15 ml |
| 70518-2224 | Tetracaine ophthalmic solution 0.5%, 15 ml |
FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drugs marketed in the United States.