July 2013 FDA Recall Dianeal Low Calcium With Dextrose by Baxter Healthcare Corp.
D-831-2013 - Defective Container
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corp. on July 24, 2013 for the product Dianeal Low Calcium With Dextrose. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-831-2013
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
07-24-2013
08-07-2013
39,486 containers
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
06-24-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07
Batch or Lot Expiration Information
Lot# Product Code: L5B4826
Lot# : C886820, Exp 11/14
