Drug product
S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX
D-0198-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 x 30 mL vials
- Official record key
drug-enforcement:D-0198-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06272019DT@08, BUD: 9/27/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility