Drug product
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0440-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 5 ml vials
- Official record key
drug-enforcement:D-0440-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09112018@10 BUD: 1/2/2019; 09212018@9 BUD: 1/12/2019; 11132018@10 BUD: 2/27/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility