FDA MedWatch - Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance

"FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Sat, 16 Jan 2016 19:31:17 -0600

Title:     FDA MedWatch - Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance

  Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance
AUDIENCE: Patient, Pharmacy
ISSUE: 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, and veterinarians within California.
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.
BACKGROUND: 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 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. 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.
RECOMMENDATION: 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.
Customers with questions regarding this recall can contact Abbott's Compounding Pharmacy by phone Monday thru Friday, 9:00am to 5:00pm at (510) 548-8777, or email its media representative at tpark@xxxxxxxxxxxxxxxxx.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

View the MedWatch Safety Alert, including links to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm482102.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm 
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