Drug product
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
D-0431-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 10 ml bottles
- Official record key
drug-enforcement:D-0431-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 11072018@10 BUD: 12/22/2018
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility