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Warfarin Recall from Upjohn-Labeling Problem With 10 mg Tablets Found In 3mg Bottles

Posted Feb 23 2011 3:04pm

This is a big deal to not confuse the two strengths as this the drug is used to thin blood.  The upside though is that the tablets look different and hopefully the image pharmacists who are responsible for filling our prescriptions will notice this if they run across one of the recalled bottles.  At the link below you can read the lot numbers of all the Upjohn products included in the recall, again what a crappy system the FDA has here for this and again if bar coding were used to readily identify it would sure help with avoiding some items slipping through the cracks.  Once scan with a cell phone could check the bottle easily instead of this long entailed process. 

From the FDA Website:

“FOR IMMEDIATE RELEASE - February 18, 2011 - Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.”

FDA Publishes Information on How to Identify Recalls – Why Not Scan That Stent With A Cell Phone and Make It Easy for the Public and Manufacturers To Keep Up, Notify And Automate Compliance

Tags for Use in Healthcare – Medical Stents, Medications - One Scan Away From Safety Information in Real Time

Anybody remember the Dennis Quaid incident with the liquid formula of Warfarin?   If a consumer took an 10 mg tablet instead of a 3 we could have an overdose and medical errors here.  BD 

WASHINGTON -- The maker of generic warfarin tablets recalled last week has issued an expanded recall that includes six other drug product lines packaged on the same packaging line. image

The recall now affects 28 lots of 16 different products packaged from May 17, 2010, to Nov. 17, 2010, in addition to the lot initially pulled with NDC# 0832-1214-00 and an expiration of September 2012, a statement from Upsher-Smith Laboratories said.

Product labels affected include:

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