In an enforcement report issued last week by the U.S. Food and Drug Administration, the FDA announced that the Cambridge, Massachusetts-based Genzyme Corporation had voluntarily issued national recall notices of its product Fludara ...
Wareham, MA (PRWEB) February 21, 2012
Gilman Law LLP, a Massachusetts products liability law firm dedicated to protecting the rights of those injured by defective drugs and medical devices, is investigating claims involving the recently recalled Fludara leukemia drug.
In an enforcement report issued last week by the U.S. Food and Drug Administration(http://www.fda.gov), the FDA announced that the Cambridge, Massachusetts-based Genzyme Corporation had voluntarily issued national recall notices of its product Fludara on January 31, 2012 and February 1, 2012. The reason for the recall was attributed to “lack of assurance of sterility,” according to the enforcement report and was based on a joint inspection by the FDA and the European Medicines Agency (EMA) conducted at the manufacturer Ben Venue Laboratories in Bedford, Ohio in November 2011.
According to a recent Bloomberg report, Genzyme conducted the recall as a precautionary measure after Ben Venue was cited last year by the FDA and EMA for “serious deficiencies,” an announcement made by Genzyme in an e-mail sent by Carrie Brown, a company spokeswoman. (http://www.bloomberg.com/news/2012-02-15/sanofi-s-genzyme-recalls-9-380-vials-of-fludara-leukemia-medicine.html) “No issue has been identified with Fludara,” the company said. “However, defects potentially associated” with deficiencies at Ben Venue “raise the possibility for hypersensitivity reactions.”
Such allergic reactions can sometimes be rare, according to a news report issued by Reuters on the Fludara recall. “Similar reactions have been associated with the active ingredient fludarabine but not have been clearly attributed to the Ben Venue Laboratories manufactured lot.” Fludara has not been manufactured by Ben Venue Laboratories since June 2010, so later batches were not part of the recall, Reuters reported.
The recall includes Fludara (fludarabine phosphate) for injection, 50 mg, single dose vials, for intravenous prescription use only and involves NDC Number 50419-511-06, according to the FDA. The recall number is D-1203-2012 and involves Lot Number 2020898, expiration date of June 2013.
Free Legal Consultations Offered by Gilman Law LLP
Gilman Law LLP, a leading Massachusetts law firm, is offering free, no obligation lawsuit consultations to the families of victims who may have suffered injury associated with the use of Fludara. The Massachusetts products liability law firm is also accepting lawsuit clients on a contingency basis. More information, as well as the opportunity to arrange for a free lawsuit consultation, is available at http://www.Gilmanlawllp.com. Free case evaluations may also be arranged by calling Toll Free at (888) 252-0048.
About Gilman Law LLP
A leading Massachusetts law firm with offices in Massachusetts and Florida, Gilman Law LLP has been recognized for delivering successful results to their clients across a broad range of claims stemming from consumer product injury, mass tort, and class action lawsuits. For over 32 years, the Gilman Law LLP team of highly experienced lawyers has earned renown for tireless work on behalf of their clients on many of today’s most challenging and important legal issues. More information about personal injury and product liability claims and the opportunity to arrange for a free lawsuit evaluation are available at http://www.gilmanlawllp.com. Free case evaluations may also be arranged by calling Toll Free at 1-877-428-7374.
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