Recalls / Class I

Class ID-1163-2014

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 Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), 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) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14

Why it was recalled

Presence of Particulate 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: 716,544 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-1163-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.