Drug product
LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
D-973-2013
Product summary
- Event
- Event 65876
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-973-2013
Official wording
Reason: Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Code information: 02262013@10, 03062013@29, 06252013@17, 07092013@18, 05092013@14
Distribution pattern: USA nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility