Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events

Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. Note: an earlier version of this news release indicated that the recall applied to all unexpired sterile compounded products dispensed since May 9, 2013; however, the recall applies to any sterile medication that has not reached its expiration date, including all strengths and dosage forms.

FDA awards contract to develop promising new technology to test radiation countermeasures

The U.S. Food and Drug Administration has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness.

FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding

The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX. There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.

Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events

Specialty Compounding, LLC, a subsidiary of Peoples Pharmacy Inc., is voluntarily recalling all lots of sterile medications within expiry. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding.

FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.