Safety Alerts & Recalls

What does this mean?

This recall for Intron A was issued at a warehouse/pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. If you take Intron A and are concerned, you should consult with your doctor.

Schering Recalls Several Lots of Intron A

Schering Corp. has recalled several lots of Intron A Multidose Pens because these lots failed the routine stability tests performed by the manufacturer. The following strengths and lot numbers have been recalled: 1) Intron A 3 MIU Multidose Pen, 6 doses of 3 million IU/0.2 mL per box - Lot numbers 8-CO-2004, 9-CO-2001, 9-CO-2002, 9-CO-2003;

2) Intron A 5 MIU Multidose Pen, 6 doses of 5 million IU/0.2 mL per box - Lot numbers 8-CO-1003, 8-CO-1004, 9-CO-1000, 9-CO-1001, 9-CO-1002, 9-CO-1003;

3) Intron A 10 MIU Multidose Pen, 6 doses of 10 million IU/0.2 mL per box - Lot numbers 8-CO-3005, 9-CO-3000, 9-CO-3001, 9-CO-3002, 9-CO-3003

Intron A contains the active ingredient Interferon alfa-2b, recombinant and is used in the treatment of many conditions, including leukemia, melanoma, lymphoma, and hepatitis. This recall alert only applies to the select lots of Intron A. No other Intron A products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-03-31
Last Updated: 2010-04-02
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