Drug product
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
D-1413-2014
Product summary
- Event
- Event 68577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,810 containers
- Official record key
drug-enforcement:D-1413-2014
Official wording
Reason: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Code information: Lot #: C926923, Exp 01/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter