Drug product
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
D-0017-2017
Product summary
- Event
- Event 75230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76,315 total units, all products
- Official record key
drug-enforcement:D-0017-2017
Official wording
Reason: Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Code information: All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility