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Adverse Reactions to Compounded Steroid Injections from Tennessee Pharmacy


The FDA is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. At least one of these appears to involve fungus.

 

Out of an abundance of caution, the 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 sterile practices at Main Street will be thoroughly reviewed. An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication.

 

See the FDA Alert

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

 

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