Ameridose recalls all products - no adverse reactions to any product reported at this time

[Catbird]

This is a developing story and no official announcements have been released as of yet.

Reuters:

Firm linked to US meningitis outbreak recalls all drugs

"Ameridose, the sister company to the U.S. pharmacy linked to a national outbreak of meningitis that has killed 28 people, on Wednesday announced it was recalling all its products, in a move to cooperate with U.S. and state regulators.

The Westborough, Massachusetts-based company said the U.S. Food and Drug Administration has asked it to improve its sterility testing processes.

The company said it had not received any reports of adverse reactions to the products it is recalling.

"Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health," the company said in a statement."

 

[Catbird]

Re: Ameridose recalls all products - no adverse reactions to any product reported at this time

Statement from Ameridose:

Ameridose Issues Recall of All Products​

October 31, 2012

Dear Customer:

Ameridose is conducting a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.


During the course of its on-going inspection of our facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose's sterility testing process. Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products. Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations.

Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo shown above. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com.

If you have any Ameridose products on hand, immediately examine your inventory and quarantine products subject to this recall. This recall should be carried out to the user level. Please complete the attached form regarding the current status of these lot(s) and return the form to Ameridose by fax at 508-656-6596, or by email at amdservice@ameridose.com. We then will contact you to arrange for return of all materials. We thank you for your cooperation, and apologize for any inconvenience.

If you have questions regarding this recall, please contact us at 888-820-0622.

Sincerely,

Ameridose, LLC
205 Flanders Road, Westborough, MA 01581
Email: amdservice@ameridose.com
www.ameridose.com

 

[Catbird]

Re: Ameridose recalls all products - no adverse reactions to any product reported at this time

FDA NEWS RELEASE

For Immediate Release: Oct. 31, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reports voluntary recall of all Ameridose drug products​

The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed at www.ameridose.com.

The FDA is currently conducting an inspection of Ameridose?s facility. Although this inspection is ongoing, the FDA?s preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Most products produced at and distributed by this facility are represented by Ameridose to be sterile products. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to cease all pharmacy and manufacturing operations starting on Oct. 10, 2012.

This recall is not based on reports of patients with infections associated with any of Ameridose?s products, and the agency recommended this recall out of an abundance of caution. Therefore, at this time, the FDA is also recommending that health care professionals do not need to follow up with patients who received Ameridose products. Health care professionals should stop using Ameridose products at this time, and return them to the firm.

Hospitals, clinics, health care professionals, and other customers with Ameridose products on hand should contact Ameridose at 888-820-0622 to obtain instructions on how to return products to Ameridose.

?The FDA?s top priority is to ensure that drugs are safe for the American public,? said FDA Commissioner Margaret A. Hamburg, M.D.

Together with the State of Massachusetts, the FDA commenced the current inspection of the Ameridose facility as part of the agency?s ongoing fungal meningitis outbreak investigation. Ameridose is a company sharing common management by the same parties as New England Compounding Center (NECC) of Framingham, Mass., the firm associated with compounded drugs linked to the ongoing fungal meningitis outbreak.

?Because the preliminary results of the FDA?s inspection raise concerns about the sterility assurance of Ameridose?s products, the FDA is advising health care professionals to stop using all Ameridose products and follow the recall procedures provided by the firm,? explained Janet Woodcock, M.D., director of FDA?s Center for Drug Evaluation and Research.

The FDA has identified some Ameridose products that currently appear on the critical shortage list. These products were in shortage before the Ameridose recall, but supplies may be further affected as a result of the Ameridose recall. The FDA is working with alternative manufacturers to maintain supplies of these life-saving drugs.

?The agency is taking all steps within its authority to help prevent or alleviate shortage situations and to minimize the impact this recall may have on drug supplies,? added Commissioner Hamburg.

As new information becomes available, the FDA will issue additional public communications.

Health care professionals and patients may dial the FDA?s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA?s MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

For more information:

Ameridose news release
Update on Fungal Meningitis
Impact of Ameridose shutdown and recall on drug supply

 

[Catbird]

Re: Ameridose recalls all products - no adverse reactions to any product reported at this time

Recalled U.S. drugs not licensed in Canada

"Medicines bought or distributed in Canada are almost certainly not affected by the latest major U.S. recall by a pharmaceutical company tied to a deadly meningitis outbreak.

...Ameridose is not licensed to make any health products for the Canadian market, according to Health Canada's Drug Product Database. The agency said earlier this week that the same holds true for the New England Compounding Center, and added that it had no evidence that any of the Massachusetts firm's products were being imported, sold or used in Canada."