Covidien Heparin Lots Recalled

[icnmgrjill]

The heparin recall continues to expand as more companies discover they were sold contaminated ingredients from China.

FOR IMMEDIATE RELEASE -- MANSFIELD, Massachusetts – March 28, 2008 - Covidien, formerly Tyco Healthcare, was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. The voluntary recall affects the following 32 lots manufactured and distributed by Covidien in the United States.

Product Lot Numbers

REF # 8881580121
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 10mL

7082274
7113214

REF # 8881580123
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe, 3mL

7051524
7113214

REF # 8881580125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL

7051524
7082274
7113164
7113174

REF # 8881580300
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe
2.5mL in 3mL syringe

7051444

REF # 8881581125
Monoject PreFillTM 10U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula

7082274

REF # 8881590121
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 10mL

7113064

REF # 8881590123
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 3mL

7041194
7072154
7113034
8010194

REF # 8881590125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL

7041194
7102804
7041204
7113034
7051534
7113044
7051544
7113054
7051554
7113104
7071924
7113114
7072034
7113154
7072044
8010064
7072054
8010114
7072064
8010134
7072154
8010174
7082284

REF # 8881591125
Monoject PreFillTM 100U/mL Heparin
Lock Flush Syringe 5mL, with BLUNTIP plastic cannula

7082284

Covidien began recalling the lots today as a precautionary measure. This product recall was initiated due to a notification received from the supplier, SPL, disclosing that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the Company is committed to following the direction of the Food and Drug Administration (FDA) regarding this matter.

The FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. As indicated in the notification issued by the supplier SPL, typical symptoms include anaphylactic-like reactions such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Adverse reactions or quality problems experienced in the U.S. with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178

Customers who have product in their possession from the recalled product lots should discontinue use immediately. Patients reporting any problems that may be related to the use of this product should be advised to contact a physician. Customers with questions about the return of recalled product should contact the Return Coordinator at 1-800-346-7197, ext. 8677, between 8:30am – 5:00pm (ET), Monday through Friday.

[bluangel]

Thank you so much for the information you have provided. I was using Baxter herparin and did have the adverse reactions and they could not understand why. If I did not go online last night I would have never know. My platlet levels also dropped very very low as well as the pain and burning.
I did call my pharmacy and they were still under the assumption it was lots. I am waiting for a call back from my doctors office to see if they knew.
Thank you again for all that you do.

[Katrina]

Very sorry blueangel that you needed to come online to find out. I am disapointed with the lack of publicity that this has gotten since there were a number a deaths and so many suffering. Too many people had to come online to learn this...what has happened to those that don't have that option? I so hope that you get better soon!!!! Prayers are with all those effected by this!

[blueangel]

Thank you very much. I am very worried about all those they do not know.
I am hoping to get beeter soon also and everyone effected also.

Thank you
sending hugs
Tara

[jen74]

Geez, I hope the one I am using is safe. I use abraxis heperin. I called my pharmacy and the FDA and they said I was ok, but the way it is going, they keep recalling different brands all the time. I hope they straighten this out real quick.
Jen

[justice4j]

Hi,
I have some Abraxis Heparin and have been fine using it. My uro just increased the quantity of Elmiron for my Rx. The new quantity allows me to do instills using 2 100 mg. capsule contents per day. I sometimes still use the Abraxis Heparin in between because I'm not doing as well right now.

I've had no problems with Abraxis Heparin. I called the company, APP and they were very courteous and attentive.

I also did a search a few weeks ago and found no Abraxis lot numbers listed on the FDA listings of problematic Heparin lots.

Good luck and I hope that helps.

[justice4j]

Hi,

I meant to say the new quantity allows me to do instills using the contents of 2 100 mg. Elmiron capsulse TWICE a day.

I didn't see the edit button for that post...

[blueangel]

Hi,
I called my doctors office to see what they were using in my instillations at the office and it was Abraxis it was only my home instills that I used Baxter. Abraxis so far is ok.
But the office did say they were going to use elmiron instead for further instills. I think what you are using is ok. Good luck and I hope they still keep giving you relief.