Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance

For Immediate Release

January 16, 2016

Contact

Consumers

Abbott's Compounding Pharmacy
510-548-8777

Media

Tony J. Park
tpark@capharmacylaw.com

Announcement

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.

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.

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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Abbott's Compounding Pharmacy deeply regrets any disruption that this voluntary recall and temporary suspension of Sterile compounding services have on its Customers, but notes that safety and quality are its primary concerns.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Page Last Updated: 01/16/2016
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