FDA Announces More Compounding Pharmacy Recalls - - BioPharm International

ADVERTISEMENT

FDA Announces More Compounding Pharmacy Recalls


FDA inspections of compounding pharmacies have revealed that results of some sterility testing by third-party laboratories may be inaccurate, causing potential risk to patients. University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level. The recall is a result of FDA inspections of methods used by an independent third-party laboratory to assess sterility. FDA believes the sterility test results may not be reliable and there may be microbial contamination in products intended to be sterile.

Last week, FDA announced a voluntary recall of products from Medaus Pharmacy, including sterile compounded consumer products, due to inability to confirm that the quality control testing performed by an independent, third-party laboratory was conducted in a manner consistent with standards.

Source: FDA.gov

 

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Author Guidelines

Click here