Drug product
S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX
D-0259-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x50 ml plastic container
- Official record key
drug-enforcement:D-0259-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07162019DT@05 exp: 8/14/2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility