Drug product
S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx.
D-0258-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22x10 ml glass vial
- Official record key
drug-enforcement:D-0258-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # S06112019DH@13, Exp 9/11/19; S06162019DH@03, Exp 9/16/19; S06182019DH@08, Exp 9/18/19; S06242019DH@12, Exp 9/24/19; S07162019DT@10, Exp 10/16/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility