Drug product
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
D-1147-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67601
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115,500 Vials
- Official record key
drug-enforcement:D-1147-2014
Official wording
Reason: Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Code information: Lot 25-097-DK; Exp 01/01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter