BETHESDA, MD 16 December 2009— The Medicines Company, which markets clevidipine butyrate under the brand name Cleviprex, announced today that it is recalling 11 lots of the injectable calcium channel blocker because of the "potential presence of visible particulate matter."
Although only "sub-visible" stainless steel particles were found in some vials during a routine annual inspection, the company said, those particles can aggregate. If they do, the resultant particles may become visible and theoretically be large enough to reduce blood flow in capillaries, damage tissues, or start inflammatory reactions, the company explained.
The 11 lots are 61-978-DW, 61-979-DW, 61-980-DW, 63-385-DJ, 63-386-DJ, 63-266-DJ, 64-453-DJ, 68-404-DJ, 68-405-DJ, 68-406-DJ, and 69-830-DJ.
A company spokeswoman said vials in the lots beginning with the digits 61, 68, or 69 contain 50 mL of drug product. Vials in the other four lots contain 100 mL.
According to Cleviprex`s labeling, clevidipine butyrate injectable emulsion is a milky white liquid. The vials are supposed to be stored long term at 2–8 °C.
The company wants hospitals to contact their wholesaler or distributor to arrange the return of any unused vials from the 11 lots.
Vials from other lots are being shipped to wholesalers and can be ordered by hospitals, the company added.
Questions about the recall should be directed to the company at firstname.lastname@example.org or 888-977-6326, 8 a.m. to 5:30 p.m. EST Monday through Friday.
Hospira Inc. manufactures Cleviprex for The Medicines Company, the spokeswoman confirmed.