Parenteral

One lot of Calcium Gluconate Injection, USP, 10%, 100 mL Pharmacy Bulk Package, has been recalled by American Regent because the vials may contain silicone particles, the company reported in a statement posted to FDA's Web site. The lot is #1006, Expiration Date: January 2013, NDC # 0517-3900-25. No other lots or sizes are involved.

SGD's flat-bottom, lighter-weight vials with better glass distribution are now available in 20-, 30-, and 50-ml capacities. The EasyLyo range initially featured 5- and 10-ml versions, and user interest encouraged SGD to expand its offerings.

Technical studies showed that EasyLyo is 5 to 10 times more resistant than a standard vial in terms of vertical load resistance. Twice more resistant again in terms of the radial load resistance: pressure exerted during the loading/unloading in the liophilizator, than a standard vial.

Maik W. Jornitz, group vice president of Global Marketing & Product Management for Filtration/Fermentation Technologies at Sartorius Stedim Biotech, is now chair of the board of the Parenteral Drug Association (PDA). The PDA, headquartered in Bethesda, MD, provides science, technology, and regulatory information and education for the global pharmaceutical and biopharmaceutical community.