Drug product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01
D-0421-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2562 syringes
- Official record key
drug-enforcement:D-0421-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-15@2 12/28/2021 & 11-2021-02@3 02/14/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility