Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices, and clinics, within California.
All recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.The recall was issued after a series of onsite inspections by the FDA. Out of an abundance of caution, Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections. To date, Abbott's Compounding Pharmacy has not received any reports of any adverse effects or injuries, and the recalled products were distributed exclusively within the state of California directly from its Berkeley, California pharmacy location.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication