Drug product
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
D-0293-2015
Product summary
- Event
- Event 68171
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,152 Containers
- Official record key
drug-enforcement:D-0293-2015
Official wording
Reason: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Code information: Lot #: NC082768, Exp 12/23/2014
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter