Drug product
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
D-1218-2014
Product summary
- Event
- Event 67080
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
drug-enforcement:D-1218-2014
Official wording
Reason: Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Code information: Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013
Distribution pattern: AZ
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility