Recalls / Class II
Class IID-0293-2015
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.
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Intravenous
- NDC
- 0338-5197
- FDA application
- ANDA075591
- Affected lot / code info
- Lot #: NC082768, Exp 12/23/2014
Why it was recalled
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.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 19,152 Containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-04-24
- FDA classified
- 2014-12-10
- Posted by FDA
- 2014-12-17
- Terminated
- 2015-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0293-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.