Drug product
SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
D-1308-2015
Product summary
- Event
- Event 71618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67.5 mL
- Official record key
drug-enforcement:D-1308-2015
Official wording
Reason: Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Code information: Lot #s: 04162015@41, BUD: 10/13/2015; 03122015@42, BUD: 7/10/2015
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility