Recalls / Class I
Class ID-1209-2015
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
5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
- Brand name
- Dextrose
- Generic name
- Dextrose Monohydrate
- Active ingredient
- Dextrose Monohydrate
- Route
- Intravenous
- NDCs
- 0338-0017, 0338-0023
- FDA application
- NDA016673
- Affected lot / code info
- Lot #: C963413 and C963413A, Exp 7/31/2016
Why it was recalled
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
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
- 402,284 bags
- Distribution pattern
- US, Puerto Rico, and Bermuda
Timeline
- Recall initiated
- 2015-03-24
- FDA classified
- 2015-07-06
- Posted by FDA
- 2015-07-15
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1209-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.