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Thread: Re: Lantus recall letter dated September 19, 2011

  1. #1

    Default Re: Lantus recall letter dated September 19, 2011

    This was sent to me from a forum member:
    http://www.fda.gov/Safety/Recalls/En.../ucm285791.htm

    PRODUCT
    Lantus (insulin glargine [rDNA origin] injection) 10 mL Vial, 100 units/mL, Rx only, in cartons of 1 vial each; NDC 0088-2220-33. Recall # D-1132-2012
    CODE
    A1259, 1/31/2013 A1271, 2/28/2013 A1295, 3/31/2013
    RECALLING FIRM/MANUFACTURER
    Recalling Firm: Sanofi-aventis US, Inc., Bridgewater, NJ, by letters dated September 19, 2011.
    Manufacturer: Gruppo Lepetit Srl, Anagni, Italy. Firm initiated recall is ongoing.
    REASON
    Lack of Assurance of Sterility.
    VOLUME OF PRODUCT IN COMMERCE
    226,880 cartoon boxes (1 vial/box)
    DISTRIBUTION
    Nationwide
    Last edited by Ellen; 01-09-2012 at 08:01 AM.

  2. #2

    Default

    Ellen I have been trying to figure out whether or not our Lantus is in this group of recalled insulin. NDC 0088-2220-33 is the National Drug Code and is assigned to a particular drug by the FDA for the purpose of identification of the manufacture. So that number will be on every box and bottle no matter what the batch or lot# is.

    What I am trying to figure out is where on my boxes and bottles to find these numbers (in bold) that are listed on this FDA report.
    CODE
    A1259, 1/31/2013 A1271, 2/28/2013 A1295, 3/31/2013

    I'm assuming the dates are expiration dates but I don't find anything on my boxes that say "code". I do see something by the expiration dates that say "Lot". Are those lot #s what I should be looking at to compare with these "code" numbers provided in this report?
    12 year old son T1 diagnosed @ age 10, July 16 2010
    MDI: Humalog & Lantus

    Home schooling my son for the first time this year.


    "I wanted a perfect ending. Now I've learned, the hard way, that some poems don't rhyme, and some stories don't have a clear beginning, middle, and end. Life is about not knowing, having to change, taking the moment and making the best of it, without knowing what's going to happen next. Delicious ambiguity". Gilda Radner, 1946-1989

  3. #3

    Default

    Do you have the box for the 10 ml vials? (are these pen vials?)

    I suggest you contact sanofi directly

    Contact us

    Sanofi US
    55 Corporate Drive
    Bridgewater, NJ 08807

    Tel: 800-981-2491

    Please let us know what you find out. Thanks .
    Last edited by Ellen; 01-09-2012 at 08:02 AM.

  4. #4

    Default

    Quote Originally Posted by MamaBear View Post
    Ellen I have been trying to figure out whether or not our Lantus is in this group of recalled insulin. NDC 0088-2220-33 is the National Drug Code and is assigned to a particular drug by the FDA for the purpose of identification of the manufacture. So that number will be on every box and bottle no matter what the batch or lot# is.

    What I am trying to figure out is where on my boxes and bottles to find these numbers (in bold) that are listed on this FDA report.
    CODE
    A1259, 1/31/2013 A1271, 2/28/2013 A1295, 3/31/2013

    I'm assuming the dates are expiration dates but I don't find anything on my boxes that say "code". I do see something by the expiration dates that say "Lot". Are those lot #s what I should be looking at to compare with these "code" numbers provided in this report?

    Yes, expiration date and 'lot' number. I have one of the A1271 w/ expiration date of 2/13
    K, 11yrs, dx 1/06 @35months
    Pumping Since 7/06 w/ MM
    PUMPING w/T:Slim 5/14
    Apidra
    Celiac dx 5/08
    Cgms-ing 11/07
    Dexcom G4 2/14
    Podding for 'tubing' breaks 4/11

  5. #5

    Default

    Quote Originally Posted by Ellen View Post
    Do you have the box for the 10 ml vials? (are these pen vials?)

    I suggest you contact sanofi directly

    Contact us

    Sanofi US
    55 Corporate Drive
    Bridgewater, NJ 08807

    Tel: 800-981-2491

    Please let us know what you find out. Thanks .
    No, not pen vials. Its the regular vial of insulin. The numbers are lot numbers and expiration dates.
    K, 11yrs, dx 1/06 @35months
    Pumping Since 7/06 w/ MM
    PUMPING w/T:Slim 5/14
    Apidra
    Celiac dx 5/08
    Cgms-ing 11/07
    Dexcom G4 2/14
    Podding for 'tubing' breaks 4/11

  6. #6

    Default

    I just got off the phone with them. Our vials are ok thankfully. The numbers listed as "code" are the lot #s.
    12 year old son T1 diagnosed @ age 10, July 16 2010
    MDI: Humalog & Lantus

    Home schooling my son for the first time this year.


    "I wanted a perfect ending. Now I've learned, the hard way, that some poems don't rhyme, and some stories don't have a clear beginning, middle, and end. Life is about not knowing, having to change, taking the moment and making the best of it, without knowing what's going to happen next. Delicious ambiguity". Gilda Radner, 1946-1989

  7. #7

    Default

    Glad to know you're okay. Per their private tweet

    Pls contact Sanofi US Medical Information at 1-800-633-1610 w/ any questions. That team is equipped to assist. Thanks!

  8. #8

    Default

    I should say too that they actually answered VERY quickly. I was surprised, thought I would be on hold MUCH longer. The rep I talked to was also very friendly. Good customer service!
    12 year old son T1 diagnosed @ age 10, July 16 2010
    MDI: Humalog & Lantus

    Home schooling my son for the first time this year.


    "I wanted a perfect ending. Now I've learned, the hard way, that some poems don't rhyme, and some stories don't have a clear beginning, middle, and end. Life is about not knowing, having to change, taking the moment and making the best of it, without knowing what's going to happen next. Delicious ambiguity". Gilda Radner, 1946-1989

  9. #9

    Default

    Hmm so I just received a letter from them with a form enclosed. They want me to fill out this form including our endo's name and address, along with the doctor's description of why my son needs Lantus. What on earth do they need that info for?
    12 year old son T1 diagnosed @ age 10, July 16 2010
    MDI: Humalog & Lantus

    Home schooling my son for the first time this year.


    "I wanted a perfect ending. Now I've learned, the hard way, that some poems don't rhyme, and some stories don't have a clear beginning, middle, and end. Life is about not knowing, having to change, taking the moment and making the best of it, without knowing what's going to happen next. Delicious ambiguity". Gilda Radner, 1946-1989

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