Drug product
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
D-1358-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 68048
- Status
- Terminated
- Classification
- Class I
- Quantity
- 85,680 vials
- Official record key
drug-enforcement:D-1358-2014
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 #: 34-440-DD, Exp 10/15
Distribution pattern: Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter