Certain lots of Sanofi Pasteur H1N1 vaccine
will expire Feb. 15
Vaccine manufacturer Sanofi Pasteur has announced that 50 lots of its monovalent 2009 (H1N1) vaccine in pre-filled syringes have a shorter shelf life than printed on the label. Physicians must cease to administer all vaccines from these lots after Feb. 15, regardless of the stated expiration date.
Sanofi notified the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration that the affected lots are losing their potency more rapidly than expected, causing them to expire earlier than the label indicates. The manufacturer reports no safety concerns with these lots, which were shipped to providers between November 2009 and January 2010, and patients who received vaccines from these lots need not receive another dose of the vaccine. The manufacturer will not produce or distribute H1N1 vaccine in pre-filled syringes after Feb. 15.
Sanofi conducted a related recall recently, which involved lots from Sanofi Pasteur’s 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. Neither of these actions affects Sanofi Pasteur’s 2009 H1N1 vaccine in multi-dose vials.
Physicians with vaccine in the affected lots should discard the vaccines in an appropriate manner, reporting to the Vaccine Ordering and Reporting System if applicable. They may also return the product for destruction to Sanofi Pasteur Inc., c/o Capital Returns, 6101 N. 64th Street, Milwaukee, WI 53218.
For a complete list of the Sanofi Pasteur monovalent 2009 (H1N1) influenza vaccine in pre-filled syringes with shorter expiration go to http://www2a.cdc.gov/han/ArchiveSys/ViewMsgV.asp?AlertNum=00309. Other questions can be directed to the CDC’s toll-free information line at (800) 232-4636. Or call Sanofi Pasteur Customer Services at (800) 822-2463 or visit www.vaccineshoppe.com.