Drug product
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
D-0477-2019
Product summary
- Event
- Event 81810
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 10 ml vials
- Official record key
drug-enforcement:D-0477-2019
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 11132018@8 BUD: 12/28/2018
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Sterility assurance
Lack of sterility