Vaccines, Blood & Biologics
Important Information Regarding Sanofi Pastuer’s Influenza A (H1N1) 2009 Monovalent Vaccine in Multidose Vials
DATE NOTIFICATION INITIATED:
August 16, 2010
Influenza A (H1N1) 2009 Monovalent Vaccine
National Drug Code (NDC) 49281-640-15
5mL Multidose Vials
MANUFACTURER:
Sanofi Pasteur
Swiftwater, PA
REASON:
This notification informs health care professionals that all lots of Influenza A (H1N1) 2009 Monovalent Vaccine in multidose vials distributed by Sanofi Pasteur in the U.S. will have a shorter expiration period than indicated on the label. These vaccines must not be used after September 15, 2010 regardless of the expiration date imprinted on the package.
This action applies only to the lots of Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine in multidose vials distributed in the U.S. This action does not impact any presentations of Sanofi Pasteur’s seasonal influenza vaccines, Fluzone, Influenza Virus Vaccine or Fluzone High-Dose, Influenza Virus Vaccine.
Lot Number | Labeled Expiration Date DD MMM YY | Re-assigned Expiration Date |
|---|---|---|
UP001AA | 09 MAR 11 | September 15, 2010 |
UP002AA | 09 MAR 11 | September 15, 2010 |
UP003AA | 10 MAR 11 | September 15, 2010 |
UP004AA | 14 MAR 11 | September 15, 2010 |
UP005AA | 15 MAR 11 | September 15, 2010 |
UP006AA | 15 MAR 11 | September 15, 2010 |
UP007AA | 16 MAR 11 | September 15, 2010 |
UP008AA | 24 MAR 11 | September 15, 2010 |
UP009AA | 16 MAR 11 | September 15, 2010 |
UP010AA | 17 MAR 11 | September 15, 2010 |
UP012AA | 28 MAR 11 | September 15, 2010 |
UP013AA | 28 MAR 11 | September 15, 2010 |
UP015AA | 29 MAR 11 | September 15, 2010 |
UP016AA | 30 MAR 11 | September 15, 2010 |
UP017AA | 02 APR 11 | September 15, 2010 |
UP018AA | 01 APR 11 | September 15, 2010 |
UP019AA | 02 APR 11 | September 15, 2010 |
UP020AA | 03 APR 11 | September 15, 2010 |
UP021AA | 11 APR 11 | September 15, 2010 |
UP022AA | 05 APR 11 | September 15, 2010 |
UP024AA | 16 APR 11 | September 15, 2010 |
UP025AA | 13 APR 11 | September 15, 2010 |
UP026AA | 19 APR 11 | September 15, 2010 |
UP027AB | 23 APR 11 | September 15, 2010 |
UP031AA | 24 APR 11 | September 15, 2010 |
UP032AA | 24 APR 11 | September 15, 2010 |
Lot Number | Labeled Expiration Date DD MMM YY | Re-assigned Expiration Date |
|---|---|---|
UP038AA | 04 MAY 11 | September 15, 2010 |
UP039AA | 27 APR 11 | September 15, 2010 |
UP042AA | 27 APR 11 | September 15, 2010 |
UP043AA | 29 APR 11 | September 15, 2010 |
UP044AA | 20 APR 11 | September 15, 2010 |
UP050AA | 24 APR 11 | September 15, 2010 |
UP051AA | 09 MAY 11 | September 15, 2010 |
UP052AA | 05 MAY 11 | September 15, 2010 |
UP053AA | 09 MAY 11 | September 15, 2010 |
UP054AA | 09 MAY 11 | September 15, 2010 |
UP055AA | 11 MAY 11 | September 15, 2010 |
UP056AA | 11 MAY 11 | September 15, 2010 |
UP057AA | 12 MAY 11 | September 15, 2010 |
UP062AA | 13 MAY 11 | September 15, 2010 |
UP063AA | 16 MAY 11 | September 15, 2010 |
UP064AA | 16 MAY 11 | September 15, 2010 |
UP065AA | 17 MAY 11 | September 15, 2010 |
UP066AA | 17 MAY 11 | September 15, 2010 |
UP067AA | 17 MAY 11 | September 15, 2010 |
UP068AA | 18 MAY 11 | September 15, 2010 |
UP069AA | 18 MAY 11 | September 15, 2010 |
UP070AA | 19 MAY 11 | September 15, 2010 |
UP071AA | 19 MAY 11 | September 15, 2010 |
UP073AA | 20 MAY 11 | September 15, 2010 |
UP074AA | 20 MAY 11 | September 15, 2010 |
UP075AA | 20 MAY 11 | September 15, 2010 |
UP076AA | 21 MAY 11 | September 15, 2010 |
UP077AA | 22 MAY 11 | September 15, 2010 |
UP078AA | 13 MAY 11 | September 15, 2010 |
UP079AA | 23 MAY 11 | September 15, 2010 |
UP080AA | 23 MAY 11 | September 15, 2010 |
UP081AA | 24 MAY 11 | September 15, 2010 |
UP083AA | 02 JUN 11 | September 15, 2010 |
UP084AA | 02 JUN 11 | September 15, 2010 |
UP087AA | 03 JUN 11 | September 15, 2010 |
UP088AA | 03 JUN 11 | September 15, 2010 |
UP089AA | 04 JUN 11 | September 15, 2010 |
UP098AA | 04 JUN 11 | September 15, 2010 |
UP099AA | 05 JUN 11 | September 15, 2010 |
Lot Number | Labeled Expiration Date DD MMM YY | Re-assigned Expiration Date |
|---|---|---|
UP100AA | 05 JUN 11 | September 15, 2010 |
UP101AA | 07 JUN 11 | September 15, 2010 |
UP102AA | 07 JUN 11 | September 15, 2010 |
UP103AA | 07 JUN 11 | September 15, 2010 |
UP105AA | 08 JUN 11 | September 15, 2010 |
UP106AA | 08 JUN 11 | September 15, 2010 |
UP107AA | 09 JUN 11 | September 15, 2010 |
UP108AA | 09 JUN 11 | September 15, 2010 |
UP109AA | 10 JUN 11 | September 15, 2010 |
UP110AA | 10 JUN 11 | September 15, 2010 |
UP111AA | 10 JUN 11 | September 15, 2010 |
UP112AA | 11 JUN 11 | September 15, 2010 |
UP113AA | 11 JUN 11 | September 15, 2010 |
UP114AA | 13 JUN 11 | September 15, 2010 |
UP117AA | 14 JUN 11 | September 15, 2010 |
UP118AA | 13 JUN 11 | September 15, 2010 |
UP119AA | 14 JUN 11 | September 15, 2010 |
UP121AA | 15 JUN 11 | September 15, 2010 |
UF836AA | 27 MAY 11 | September 15, 2010 |
UF841AA | 30 MAY 11 | September 15, 2010 |
UF846AA | 05 JUN 11 | September 15, 2010 |
UF846AB | 06 JUN 11 | September 15, 2010 |
UF851AA | 08 JUN 11 | September 15, 2010 |
UF851AB | 09 JUN 11 | September 15, 2010 |
UF851AC | 09 JUN 11 | September 15, 2010 |
UF861AA | 11 JUN 11 | September 15, 2010 |
UF867AA | 15 JUN 11 | September 15, 2010 |
UF867AB | 14 JUN 11 | September 15, 2010 |
UF867AC | 15 JUN 11 | September 15, 2010 |
UF867AD | 14 JUN 11 | September 15, 2010 |
UF867AE | 15 JUN 11 | September 15, 2010 |
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
