Regulatory News

Abrams Royal Compounding Pharmacy initiates voluntary recall of drugs

Non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas are being voluntarily recalled, according to a press release from the U.S. Food and Drug Administration.

Injectable medications, intravenous injections, eye drops, pellet implants, nasal sprays, inhalation solutions and eye ointments are included in the recall and were distributed between June 17, 2013, and Dec. 17, 2013, according to the release.

Health care professionals who have these products should stop using them. Abrams has started notifying customers by mail and is arranging for the return of all recalled medication. Users can contact Abrams Royal at 214-349-8000.

The FDA is aware of one adverse event associated with a mineral IV injection with the lot number 11142013@74. A patient who received this product was admitted to a hospital and had blood cultures that tested positive for Stenotrophomonas maltophilia, according to the release.

Adverse reactions should be reported to the FDA’s MedWatch adverse event reporting program at www.fda.gov/medwatch/report.htm.

Non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas are being voluntarily recalled, according to a press release from the U.S. Food and Drug Administration.

Injectable medications, intravenous injections, eye drops, pellet implants, nasal sprays, inhalation solutions and eye ointments are included in the recall and were distributed between June 17, 2013, and Dec. 17, 2013, according to the release.

Health care professionals who have these products should stop using them. Abrams has started notifying customers by mail and is arranging for the return of all recalled medication. Users can contact Abrams Royal at 214-349-8000.

The FDA is aware of one adverse event associated with a mineral IV injection with the lot number 11142013@74. A patient who received this product was admitted to a hospital and had blood cultures that tested positive for Stenotrophomonas maltophilia, according to the release.

Adverse reactions should be reported to the FDA’s MedWatch adverse event reporting program at www.fda.gov/medwatch/report.htm.