FDA Recall D-0958-2016
Baxter Healthcare Corp. · Deerfield, IL
Class I — life-threatening Terminated 2313 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
Reason for recall
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Recall record
- Recall number
D-0958-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2015-12-15
- Classified by FDA Center
- 2016-06-06
- FDA published
- 2016-06-15
- Terminated
- 2022-04-15
- Recalling firm
- Baxter Healthcare Corp.
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- DEXTROSE
- Generic name(s)
- DEXTROSE MONOHYDRATE
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
0338-0719- Route(s)
- INTRAVENOUS