February 2016 FDA Recall Sodium Chloride by Baxter Healthcare Corp.
D-0731-201 - PRESENCE OF PARTICULATE MATTER
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on February 5, 2016 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0731-201
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
02-05-2016
03-09-2016
257,364 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
11-16-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
Batch or Lot Expiration Information
Lot# G120162, Exp 11/18
