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.

FDA recall notice · announced June 11, 2014 · Hospira

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Reason for recall

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Notes

Distribution: Nationwide.
Lot/code information: Lot #: 34-440-DD, Exp 10/15
Quantity: 85,680 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.