Drug product
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
D-0440-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 81403 units
- Official record key
drug-enforcement:D-0440-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17186 6/20 17345 11/20 19010 1/22 17041 2/2020 16217 8/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility