Recalls / Class I
Class ID-1591-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0338-0043, 0338-0049
- FDA application
- NDA018016
- Affected lot / code info
- Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
Why it was recalled
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
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
- a) 217,536 bags; b) 161,760 bags
- Distribution pattern
- Nationwide, Puerto Rico, Singapore, and Hong Kong
Timeline
- Recall initiated
- 2014-07-11
- FDA classified
- 2014-09-18
- Posted by FDA
- 2014-09-24
- Terminated
- 2016-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1591-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.