So far there have not been any problems associated with any Ameridose drugs. Ameridose is a different type of company which is FDA approved for distribution of injectable drugs. The company has the same owners as NECC and was actually a spin off of that company a few years back as business was good. Ameridose has already ceased manufacturing in light of the NECC situation. Ameridose is contacting customers and sending information on how to return the products. In the past it was noted there was one issue with sterility a few years ago at the plant and this recall is precautionary.
Additional Information About NECC and Ameridose Continues as FDA Inspection Report is Released
Just a couple days ago Massachusetts regulators shut down another compounding company which is not related to NECC or Ameridose called Infusion Resource and it was a surprise visit by the FDA. So far 28 people have died from the meningitis compounded drugs distributed by NECC. In the Ameridose recall, the FDA is not requiring doctors to follow up with patients. BD
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.
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.
0 comments :
Post a Comment