Drug product
SIU-Papav/Phent 24/1 mg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1461-57
D-1295-2015
Product summary
- Event
- Event 71618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 mL
- Official record key
drug-enforcement:D-1295-2015
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 #: 04232015@22, BUD 10/20/2015
Distribution pattern: Oklahoma
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility