Posted by Salvatore J. Zambri, founding member and partner
The FDA has announced that Clinical Specialties Compounding Pharmacy is recalling all sterile products due to lack of sterility assurance. We have reproduced the FDA notice in its entirity for our readers.
"Clinical Specialties Compounding Pharmacy Products: Recall – All Sterile Products Recalled Due To Lack of Sterility Assurance
AUDIENCE: Health Professional, Pharmacy, Patient
ISSUE: Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.
BACKGROUND: This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product. The Center for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.
RECOMMENDATION: Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company. Consumers or Health Care providers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 Monday through Friday between the hours of 10 am to 5 pm EST, or e-mail at email@example.com. Patients who have received any product distributed by Clinical Specialties Compounding and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/21/2013 – News Release – FDA]
[03/20/2013 – Press Release – Clinical Specialties ]
Related MedWatch Alert
[03/18/2013 – Press Release – Clinical Specialties ]"
As I have been following the compounding pharmacy investigations, I will continue to share with our readers what I learn regarding this very important consumer safety issue.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year". He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington’s best–most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2013 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers in both medical malpractice and personal injury law, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2013)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at firstname.lastname@example.org. You may also reach him at 202-822-1899.