Drug product
VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
D-0228-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 490 mL
- Official record key
drug-enforcement:D-0228-2015
Official wording
Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Code information: Lot #: 20140811@5, discard date 10/16/2014 Lot #: 20140827@12, discard date 11/25/2014
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility