FDA Discovers Microbial Contamination in Compound Pharmacy Products - - BioPharm International

ADVERTISEMENT

FDA Discovers Microbial Contamination in Compound Pharmacy Products


RELATED ARTICLES

More in GMPs/Validation

FDA has identified bacterial and fungal growth in samples from two unopened vials from two separate lots of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials during investigation of Main Street Family Pharmacy of Newbern, TN. The agency is still evaluating additional samples and lots of PF MPA, as well as other sterile products produced by Main Street. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials.

While FDA has received reports of adverse events, including skin and soft tissue abscesses, the agency stated on its website that it is “not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.” FDA, however, recommends that patients discontinue use of the products. Main Street issued a voluntary nationwide recall of all lots of all sterile products compounded by the company on May 28, 2013.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials
October 23, 2014
Pall ForteBio Releases Bioprocessing Contamination Detection Kit
October 22, 2014
Roche to Expand and Improve its Basel Site
October 22, 2014
FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis
October 22, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Author Guidelines

Click here