Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

FDA recall notice · announced March 26, 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%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Reason for recall

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Notes

Distribution: Nationwide
Lot/code information: Lot 25-220-DD, Exp 1JAN2015
Quantity: 40,360 vials
Status: Terminated
Products in this recall event:
- Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. (D-1161-2014)

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