Drug product
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL
D-0485-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 73548 units
- Official record key
drug-enforcement:D-0485-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 17008, Exp 01/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility