Silicone particles drive American Regent recall

Silicone particles have taken the place of glass chips in American Regent's most recent product recall. The Shirley, NY, distributor is reaching out to the user and consumer level for the return of one lot (#1006) of calcium gluconate injection, USP, 10%, 100 mL, made by parent company Luitpold Pharmaceuticals. Both are owned by Daiichi Sankyo.

The product, which is used to treat conditions arising from calcium deficiencies, was distributed in pharmacy bulk packaging to wholesalers and distributors nationwide. The recall notice says hospitals and other healthcare facilities should "immediately quarantine any product for return." No reason was given for why silicone particles may be present in some vials.

From last December through early June, American Regent issued 5 recalls of parenterals because of glass flake contamination. Similar recalls by other manufacturers--some going back as far as mid-2010--also occurred, prompting drug quality and authenticity consortium Rx-360 in January to begin sending alerts on the particle-contaminated injectables, citing sub-par vial glass as the culprit.

- see the recall notice