Drug product
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
D-0002-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68579
- Status
- Terminated
- Classification
- Class I
- Quantity
- 40,730 vials
- Official record key
drug-enforcement:D-0002-2015
Official wording
Reason: Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Code information: Lot # 33-545-DD, Exp. 09/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter