Drug product
METHYCOBALAMIN, preservative, 1mg/mL, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
D-0205-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 mL
- Official record key
drug-enforcement:D-0205-2015
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 #: 20140715@2, discard date: 10/13/2014; Lot #: 20140724@10, discard date: 10/22/2014; Lot #: 20140812@14, discard date: 11/1/2014; Lot #: 20140826@5, discard date: 11/1/2014;
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility