Glass delamination is being cited as the reason for two more drug recalls. American Regent is taking back one lot of cyanide-poisoning treatment sodium thiosulfate and one lot of intravenous-fluid supplement potassium phosphates injection. Both are packaged in vials and made by the drug distributor's parent, Luitpold Pharmaceuticals, owned by Daiichi Sankyo.
The sodium thiosulfate recall is for 10-mL vials while the potassium phosphates recall involves 5-mL units. Both recalls, announced late last week, reach the user level.
Delamination yields glass particle contamination. It has been the cause now of seven parenteral recalls, according to industry group Rx-360. Among them is another American Regent recall from late December of single-dose vials of sodium bicarbonate. Causes may include chemicals used in glass processing and drug formulation characteristics.
- see the American Regent announcement