of Shirley, N.Y. announced voluntary recalls of certain lots of multiple injectable products in March. The recalls include lots of concentrated sodium chloride injection, bacteriostatic sodium chloride injection, and dexamethasone sodium phosphate injection.

 

The recall notices state that the recalls were initiated because some of the vials in the recalled lots may contain visible particulates, or, in the case of the dexamethasone sodium phosphate, may “have the potential to form particulates prior to their respective expiration dates.”

 

The recalls, announced on March 15 and 16, follow a Feb. 3 recall by American Regent of one lot of potassium phosphates injection because some vials in the lot exhibited “translucent visible particles consistent with glass delamination.” In addition, the company initiated a Dec. 23 recall for lots of dexamethasone sodium phosphate injection different from those announced in March. The recall also included lots of sodium bicarbonate injection because of the possibility of the presence in some vials of particulates or the possibility of forming particulates before the expiration dates.

 

Multiple calls to the company requesting comment on the recalls were not returned. No information in the recall notices suggests whether or how the recalls might be related.

 

The three March recalls state that potential adverse events from intravenous administration of solutions containing particulates can include disruption of blood flow in small blood vessels in the lung, localized inflammation due to accumulation of inflammatory cells, and granuloma formation.

 

The products were distributed to wholesalers and distributors nationwide, according to the recall notices. The recalls were initiated at the user level, and the notices urge hospitals, doctors, and other users to quarantine the affected lots for return.

 

Source: pharmaquality