Recalls / Class I
Class ID-481-2015
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, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDC
- 0338-0553
- FDA application
- NDA020178
- Affected lot / code info
- Lot #: P317891, P317842, Exp 05/15
Why it was recalled
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
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
- 542,080 container bags
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2014-12-04
- FDA classified
- 2015-04-08
- Posted by FDA
- 2015-04-15
- Terminated
- 2017-04-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-481-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.