FDAnews Drug Daily Bulletin

FDA Issues MedWatch Alerts for Two Injectable Antibiotics

July 13, 2007

The FDA issued MedWatch alerts for two injectable antibiotics last week, one to notify physicians of a recall of Merck’s Invanz and one highlighting a new warning for Roche’s Rocephin, the agency said.

Merck July 2 sent “Dear Healthcare Provider” letters to inform customers that 75,000 vials of Invanz (ertapenem) had been recalled due to reports of glass fragments found in the product after it was reconstituted. No adulterated product was administered to patients, Merck said.
The recall was a precautionary measure, and there will be no interruption in the supply of Invanz going forward, the company said. Invanz, which is indicated for the treatment of moderate-to-severe infections, had sales of $23 million in the U.S. during the first quarter of 2007, according to Merck.

The MedWatch alert for Roche’s Rocephin (ceftriaxone) was issued to notify neonatologists, pediatricians, infectious disease specialists and hospital administrators of a new warning in physician labeling for the injectable antibiotic.

The updated label warns physicians that Rocephin, and generic versions of the product, should not be administered simultaneously with calcium-containing solutions or products, and such products should not be administered to patients within 48 hours of Rocephin dosing.