Drug product
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
D-381-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66260
- Status
- Terminated
- Classification
- Class I
- Quantity
- 119,600 vials
- Official record key
drug-enforcement:D-381-2014
Official wording
Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Code information: Lot # 23-338-DK, Exp. 11/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter