Contamination by particulate matter has led to a recall of seven lots of dexamethasone sodium phosphate, an anti-inflammatory medication distributed by American Regent, Inc.
The dexamethasone recall was announced on December 20 by the FDA, after some lots were found to contain particles that formed before the expiration date. There have been no injuries or illnesses connected to the contaminated injections.
The recall affects seven lots of dexamethasone sodium phosphate injections, USP 4 mg/ML, 30 mL Multiple Dose Vials with lot numbers 8811, 9093, 9195, 9296, 9419, 9505 and 9649. All of the recalled injections have expiration dates ranging from 12/2010 to 9/2011.
The injections were distributed to wholesalers and retailers nationwide. While the company said that the recall was precautionary due to safety concerns in its press release, it did not state what the safety risks of dexamethasone injections contaminated with particles could be. It also did not specify the nature of the contaminating particles.
Dexamethasone is a steroid that is used as an anti-inflammatory and immunosuppressant. It is often used to treat rheumatoid arthritis and often used as part of chemotherapy treatment in some forms of cancer. It is also used by mountain climbers to treat high altitude illnesses, like high altitude cerebral edema. It is sometimes used illegally by athletes for sports performance enhancement.
American Regent says it is crediting accounts for all returned products in the affected lots. Anyone with questions should call the company’s customer service department at 1-800-645-1706.