Re: Lantus recall letter dated September 19, 2011

[Ellen]

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

[MamaBear]

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?

[Ellen]

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 .

[Flutterby]

Originally Posted by MamaBear

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

[Flutterby]

Originally Posted by Ellen

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.

[MamaBear]

I just got off the phone with them. Our vials are ok thankfully. The numbers listed as "code" are the lot #s.

[Ellen]

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!

[MamaBear]

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!

[MamaBear]

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?