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U.S. Department of Health and Human Services

FDA Drug Shortages

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Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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 Peritoneal Dialysis Solutions

 Status: Currently in Shortage

 » Date first posted: 08/08/2014
 » Therapeutic Categories: Pediatric; Renal

Baxter Healthcare (Reverified 12/10/2014)

Company Contact Information:
888-229-0001

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Peritoneal Dialysis Solutions (Dianeal and Extraneal) Baxter is experiencing limited supplies. Anticipate supplies to recover by Q1 2015.

Baxter Full List of Presentations/NDCs

Demand increase for the drug
Dianeal PD4 Glucose 1,36% w/v 13,6 mg/ml Solution for Peritoneal Dialysis, 5000 mL (UK/ English label) (NDC 0941-0464-01) (SPB5215RC) Available beginning November 2014 Baxter Healthcare Corporation, in conjunction with FDA, has initiated temporary importation of Dianeal PD4 Glucose Solutions for Peritoneal Dialysis into the U.S. market to address a shortage. Please see the Dear Healthcare Professional and Dear Consumer Letters for additional product and supply information, including a Comparison Guide. Once the product is available in the United States clinicians will be able to contact their Baxter Clinical Educator for further information and it will be available for order through Baxter’s Home Care Services at 1-800-284-4060.

Please see the Dear Healthcare Professional Letter for additional product information, including a Comparison Guide.


Please see the Dear Consumer Letter for additional product information, including a Comparison Guide.
Increased demand for the product.
Dianeal PD4 Glucose 2,27% w/v 22,7 mg/ml Solution for Peritoneal Dialysis, 5000 mL (UK/ English label) (NDC 0941-0465-01) (SPB5225RC) Available beginning November 2014 Baxter Healthcare Corporation, in conjunction with FDA, has initiated temporary importation of Dianeal PD4 Glucose Solutions for Peritoneal Dialysis into the U.S. market to address a shortage. Please see the Dear Healthcare Professional and Dear Consumer Letters for additional product and supply information, including a Comparison Guide. Once the product is available in the United States clinicians will be able to contact their Baxter Clinical Educator for further information and it will be available for order through Baxter’s Home Care Services at 1-800-284-4060.

Please see the Dear Healthcare Professional Letter for additional product information, including a Comparison Guide.


Please see the Dear Consumer Letter for additional product information, including a Comparison Guide.
Increased demand for the product.
Dianeal PD4 Glucose 3,86% w/v 38,6 mg/ml Solution for Peritoneal Dialysis, 5000 mL (UK/English label) (NDC 0941-0466-01) (SPB5235RC) Available beginning November 2014 Baxter Healthcare Corporation, in conjunction with FDA, has initiated temporary importation of Dianeal PD4 Glucose Solutions for Peritoneal Dialysis into the U.S. market to address a shortage. Please see the Dear Healthcare Professional and Dear Consumer Letters for additional product and supply information, including a Comparison Guide. Once the product is available in the United States clinicians will be able to contact their Baxter Clinical Educator for further information and it will be available for order through Baxter’s Home Care Services at 1-800-284-4060.

Please see the Dear Healthcare Professional Letter for additional product information, including a Comparison Guide.


Please see the Dear Consumer Letter for additional product information, including a Comparison Guide.
Increased demand for the product.

Fresenius Medical Care North America (New 08/08/2014)

Company Contact Information:
800-323-5188

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Peritoneal Dialysis Solutions (Delflex and Stay Safe) Available

Fresenius Medical Care North America Full List of Presentations/NDCs

Other
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