Drug product
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13
D-0415-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 306,479 units
- Official record key
drug-enforcement:D-0415-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17205 07/19 08/31/2017 17206 07/19 09/13/2017 17271 09/19 11/08/2017 18003 01/20 03/06/2018 18097 04/20 05/11/2018 18166 07/20 07/26/2018 18227 09/20 10/05/2018 18246 10/20 11/16/2018 18317 12/20 12/18/2018 19080 03/21 04/22/2019 19106 04/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility