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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.