Recalls / Class I
Class ID-1162-2014
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
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
- 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 #: P285288, Exp 11/13
Why it was recalled
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 105,216 containers
- Distribution pattern
- Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Timeline
- Recall initiated
- 2013-11-21
- FDA classified
- 2014-03-14
- Posted by FDA
- 2014-03-26
- Terminated
- 2016-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1162-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.