May 31, 2013
Main Street Family Pharmacy, LLC has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those with a use by date on or before November 20, 2013. The recall is being initiated due to seven reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events is still ongoing.
These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide.
Click here for the list of products being recalled.
Out of an abundance of caution, the US Food and Drug Administration (FDA) recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:
Read the MedWatch safety alert.