Update : 1
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.
Update : 2
Subject: CDRH New Update
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| FDA Home Page CDRH Home Page Search A-Z Index |  | |
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 | 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 |  |
Update : 3
Subject: Mammography What's New Update
Mammography What's New for U.S. Food & Drug Administration (FDA) : This information has recently been updated, and is now available.
The "2007 Mammography Facility Adverse Event and Action Report."
Update : 4
Subject: Resolved Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
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Resolved Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Fri, 21 Mar 2008 15:30:00 -0500
APP has the 200 mcg vials (NDC 63323-0247-10) available and Bedford has the 200 mcg vials (NDC 55390-0880-10) available.
Update : 5
Subject: CFSAN Constituent Update - March 21, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
March 21, 2008
Clarification Letter Sent to Food Facilities Registered Under the Bioterrorism Act – U.S. Agents Have No Affiliation With the U.S. FDA
The United States Food and Drug Administration (U.S. FDA) has sent by e-mail a letter to owners and operators of food facilities registered with the U.S. Food and Drug Administration pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the agency's implementing regulation, the Registration of Food Facilities Final Rule (21 CFR §§ 1.225-1.243). The e-mail contained links to allow food facility owners and operators to view the U.S. FDA letter in English, French, and/or Spanish.
U.S. FDA's Registration of Food Facilities Final Rule requires owners and operators of all domestic and foreign facilities that manufacture, process, pack, or hold food that will be consumed in the United States to register with U.S. FDA. Registrations for foreign facilities must contain the name, address, phone number, and emergency contact phone number of its U.S. agent (if there is no other emergency contact designated in the registration) who resides or maintains a place of business in the United States. (21 CFR §§ 1.227(b)(13) and 1.232(d)).
U.S. FDA sent its letter in response to an inquiry the agency received from a foreign embassy seeking clarification on information that had been sent to a number of food facilities in its country by FDA Registrar Corporation (FDA Registrar Corp). U.S. FDA is aware that private businesses, such as FDA Registrar Corp., are offering their services to food facilities. The purpose of U.S. FDA's response is to clarify that these private businesses are not affiliated with U.S. FDA, nor do they act on U.S. FDA's behalf.
U.S. FDA's letter to facility owners and operators also notes the following regarding the registration of food facilities:
- Food facilities can register directly with U.S. FDA. There is no fee to register with U.S. FDA.
A food facility may register, update, or cancel its registration itself (or authorize another person to do so on its behalf) using the Internet at http://www.access.fda.gov/. Alternatively, a food facility may register, update, or cancel a registration by mail by requesting the appropriate form from U.S. FDA at 1-800-216-7331 (301-575-0156 outside the United States), or by e-mail at furls@fda.gov.
U.S. Agents may charge a fee for their services, which is solely an issue to be decided between the food facility and the person who agrees to serve as the food facility's U.S. Agent.
- Contrary to any suggestion by FDA Registrar Corp., food facilities should register only once. The registration does not expire.
If any of the mandatory information in a registration changes (e.g., a food facility changes U.S. Agents or food product categories manufactured at the facility), the registered food facility must update the registration within 60 days of the change. 21 CFR § 1.234. The registered food facility must cancel a registration within 60 calendar days of the reason for cancellation (e.g., facility ceases operations, ceases providing food for consumption in the United States, or the facility is sold to a new owner). 21 CFR § 1.235.
- Contrary to any suggestion by FDA Registrar Corp., food facilities do not need a certificate of registration. U.S. FDA does not issue a certificate of registration, nor does U.S. FDA recognize a certificate of registration issued by a private business. U.S. FDA issues a registration number to registered facilities. Any registered food facility may obtain its registration number by contacting U.S. FDA.
- Contrary to any suggestion by FDA Registrar Corp., food facilities that have registered and do not have their FURLS information or PIN should not re-register. Instead, a food facility can contact U.S. FDA for help at 1-800-216-7331 (301-575-0156 outside the United States), or by e-mail at furls@fda.gov.
A food facility will be asked to provide information on its company's letterhead signed by the owner, operator, or agent-in-charge of the facility to verify the information. Once U.S. FDA verifies the identity of the food facility, U.S. FDA will provide the facility access to its account. For more information about these requirements, please refer to the Final Rule and to U.S. FDA's website (The Bioterrorism Act of 2002) for Question and Answer guidance documents, tutorials, and other information. You can also ask U.S. FDA for help at 1-800-216-7331 (301-575-0156 outside the United States), or by e-mail at furls@fda.gov.
U.S. FDA also will be sharing this information with trade associations and foreign embassies and ask that they disseminate the information widely. Copies of U.S. FDA's letter also may be viewed online: Important FDA Notice Regarding Firms Offering Registration Services.
Update : 6
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).
Update : 7
Subject: MedWatch - Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall - Reports of inflammatory mass formations
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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
Update : 8
Subject: MedWatch - B. Braun Heparin Sodium Injection Solutions - Recall due to heparin-like contaminant
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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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