U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 21 Mar 2008 10:07:11 -0500 (CDT)
Subject: American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall (March 20)

American Health Packaging Announces a Recall of Approximately 1,400 Units of Heparin Sodium Vial Products as Part of Broader Baxter Recall (March 20)
Fri, 21 Mar 2008 09:42:00 -0500

American Health Packaging (AHP), a subsidiary of AmerisourceBergen Corporation (NYSE:ABC), today announced a voluntary recall of 1,421 units (25 vials per unit) of 10000 USP units/ml heparin sodium injection 1ml vials as part of the broader February 29, 2008 recall of Heparin products made by Baxter Healthcare Corporation.

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 21 Mar 2008 11:18:23 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: March 21, 2008

The following new items were added to the CDRH web pages on March 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Summary Information for: Dako TOP2A FISH pharmDx™ Kit

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 21 Mar 2008 17:07:47 -0500 (CDT)
Subject: B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (March 21)

B. Braun's Supplier Recall of Heparin API Prompts Voluntary Recall of Heparin Solutions (March 21)
Fri, 21 Mar 2008 16:06:00 -0500

B. Braun Medical Inc. was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API).

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 21 Mar 2008 21:28:55 -0500 (CDT)
Subject: MedWatch - Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall - Reports of inflammatory mass formations

FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.

Read the complete MedWatch safety summary, including links to the Recall Notice and the "Dear Healthcare Professional" letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 21 Mar 2008 21:36:01 -0500 (CDT)
Subject: MedWatch - B. Braun Heparin Sodium Injection Solutions - Recall due to heparin-like contaminant

B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.

Read the complete MedWatch 2008 safety summary, including a link to the Press Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#BBraun

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