Drug product
Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
D-0676-2016
Product summary
- Event
- Event 73090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7200 mL
- Official record key
drug-enforcement:D-0676-2016
Official wording
Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Code information: All lots
Distribution pattern: CA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility