August 2014 FDA Recall Dianeal Low Calcium With Dextrose by Baxter Healthcare Corp.
D-1610-2014 - Presence of Particulate Matter
This Class I drug recall was voluntarily initiated by Baxter Healthcare Corp. on August 7, 2014 for the product Dianeal Low Calcium With Dextrose. 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-1610-2014
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
08-07-2014
10-08-2014
50,530 bags
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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
04-28-2017
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 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Batch or Lot Expiration Information
Lot# : C940700, C940841, Exp 05/16
