Recalls / Class II
Class IID-0731-201
Product
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDC
- 0338-0048
- FDA application
- NDA017427
- Affected lot / code info
- Lot # G120162, Exp 11/18
Why it was recalled
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
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
- 257,364 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-02-05
- FDA classified
- 2016-02-26
- Posted by FDA
- 2016-03-09
- Terminated
- 2016-11-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0731-201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.