Drug product
LIDOCAINE HCL (REPKG-STERILE), 4%, solution for irrigation, 5 mL, 6 mL, and 7 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070
D-0201-2015
Product summary
- Event
- Event 69519
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49/5 mL bottles; 40/6 mL bottles; 30/7 ml bottles
- Official record key
drug-enforcement:D-0201-2015
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 #: 20140815@12, discard date: 2/16/2015
Distribution pattern: Oregon, Washington
Derived failure modes
-
Sterility assurance
Lack of Sterility