Abbott’s Compounding Pharmacy in Berkeley, Calif., is voluntarily recalling all unexpired lots of sterile compounded products because of lack of sterility assurance.
The compounded medications include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.
The recall was issued after a series of on-site inspections by FDA. “Out of an abundance of caution, Abbott’s Compounding Pharmacy is voluntarily recalling all sterile compounded products within expiry. If there is microbial contamination in products intended to be sterile, patients are at risk for serious and potentially life-threatening infections,” FDA said in a Medwatch Safety Warning.
Abbott’s Compounding Pharmacy has not received any reports of any adverse effects or injuries.
All recalled products have a label that includes the Abbott’s Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
“Customers that have recalled product should immediately stop using it and contact the pharmacy to arrange for the return of unused product. Customers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products,” FDA said.