FDA NEWS RELEASE

For Immediate Release: Dec. 21, 2013 Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy

The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.

Contaminated sterile drugs put patients at risk of serious infection. Health care professionals who have received the affected products should stop using them and follow Abrams recall instructions.

The FDA is aware of one adverse event associated with mineral IV injection produced by Abrams lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection.

Patient safety is our top priority, and giving a patient a contaminated drug could result in a serious infection, said Howard Sklamberg, director of the Office of Compliance in the FDAs Center for Drug Evaluation and Research. Using these products puts patients at an unacceptable risk, and we urge health care professionals to follow recall instructions issued by the firm.

Patients who were administered any sterile drug products produced and distributed by Abrams and have concerns should contact their health care professional.

Adverse reactions experienced with the use of any Abrams products should be reported to FDAs MedWatch Adverse Event Reporting program by: completing and submitting the report online at www.fda.gov/medwatch/report.htm; or downloading and completing the form, then submitting it via fax to 800-FDA-0178.

For more information about this recall, contact Abrams at 214-349-8000.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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