Drug product
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
D-0429-2018
Product summary
- Event
- Event 78828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 297 bags
- Official record key
drug-enforcement:D-0429-2018
Official wording
Reason: Lack of sterility assurance.
Code information: All lots remaining within expiry.
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility