Drug product
S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX
D-0207-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18x10 ml and 1x5 ml glass vials
- Official record key
drug-enforcement:D-0207-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) 03072019DH@08, Exp 9/7/19; S04042019DT@04, Exp 10/4/19; S05012019DH@04, Exp 11/1/19; S05242019DT@12, Exp 11/24/19; S06182019DH@12 Exp 12/18/19; S06182019DH@32, Exp 12/18/19; S07152019DH@02, Exp 1/15/20; b) S06202019DT@05, Exp 12/20/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility