FDA finds bacterial and fungal growth in unopened vials at US compounding pharmacy
FDA cites Main Street Family Pharmacy in Newbern, Tennessee for multiple violations, including sterility problems in the cleanroom
Inspectors from the US Food and Drug Administration (FDA) have identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials as part of an investigation at Main Street Family Pharmacy in Newbern, Tennessee.
Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by the compounding pharmacy. The FDA, in partnership with the US Centres for Disease Control, is working to identify the exact species of fungus and bacteria observed in the vials. 'We will share additional information as it becomes available,' the FDA said.
On 28 May, Main Street Family Pharmacy announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products subject to the recall have a use by date on or before 20 November 2013.
The FDA said it had received reports of adverse events from patients who received preservative free methylprednisolone acetate (80mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus, the FDA said.
The inspection report cited the pharmacy for multiple violations including failure to document the monthly cleaning, disinfection or maintenance of the facility
According to the CDC, 26 people in four states have been made ill by drugs produced by the pharmacy. They reported infections or inflammation at the site of injections. No cases have been reported in Tennessee.
‘Two patients had Enterobacter cloacae and Klebsiella pneumoniae, one had mixed bacterial culture not otherwise identified, and one had fungus highly suggestive of an Aspergillus sp,’ the CDC said.
The inspection report cited the pharmacy for multiple violations including failure to document the monthly cleaning, disinfection or maintenance of the facility.
The report also cited several sterility problems in the cleanroom, where sterile drugs are compounded. The FDA said the facility also failed to have written pest control procedures and ‘two spiders were observed in the cleanroom’.
Inspectors also noted that the pharmacy failed to take proper corrective action when tests showed that a vial of methylprednisolone acetate was overly potent.