Drug product
SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
D-1304-2015
Product summary
- Event
- Event 71618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2.5 mL
- Official record key
drug-enforcement:D-1304-2015
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 #: 03192015@27, BUD 07/13/2015
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility