| MICROBIAL ADVERSE EVENT CAUSES RECALL |
| 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 FDA’s 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. COMMENT: An  adverse event notification was provided to the FDA for a single product,  mineral IV injection, produced by Abrams’, Lot number 11142013@74. Blood cultures tested positive for  Stenotrophomonas maltophilia, a gram-negative bacterium. Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection. One may  ask the question why ALL non-expired drug products produced and distributed  for sterile use by Abrams was being recalled.  Because S. maltophilia is often found within Purified Water, and, because it appears that most if not all of these products used a water source that may have been derived from Purified Water that was present in their  facilities and/or the facilities were cleaned with Purified Water, then the bacterium would have the ability to contaminate their facilities. If Water for Injection were used for the manufacture of the final product, the equipment used to manufacture the water would have killed this bacterium.  Thus, while a Root Cause analysis will determine the actual cause, speculation at this time suggests that the problem would have come from Purified Water. |
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