Drug 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.
D-1161-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66503
- Status
- Terminated
- Classification
- Class I
- Quantity
- 40,360 vials
- Official record key
drug-enforcement:D-1161-2014
Official wording
Reason: 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.
Code information: Lot 25-220-DD, Exp 1JAN2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter