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10/14/2003

Gamimune Recalled by Bayer

Cheryl Thompson

Bayer Corp. is recalling four lots of Gamimune N, 10%, an intravenous (i.v.) immunoglobulin product, and initiating a "product distribution hold" on three other lots as a precaution.

The actions are the result of the company receiving a higher-than-expected rate of adverse-event reports describing allergic reactions related to four lots of the immunoglobulin product, according to notices dated Oct. 3.

Affected by the recall are the following lots of Gamimune N, 10%:

  • 26N33W1 (expiration date May 14, 2006),                   
  • 26N34C1 (May 17, 2006), and                   
  • 26N35V1 and 26N36V1 (May 23, 2006).

The company indicated that the above lots were released to the market in June and July. All vials in these lots should be returned to the company.

As a precaution, the company wants anyone in possession of other lots of Gamimune N, 10%—26N37J1 (expiration date July 24, 2006), 26N37P1 (July 30, 2006), and 26N37R1 (Aug. 1, 2006)—to hold onto those vials until further notice, which should arrive by Oct. 17. The lots affected by the "distribution hold" order were released to the market in mid-September.

Although Bayer did not request return of vials affected by its hold notice, the Food and Drug Administration today reported that the recall involved seven lots—the four lots recalled by Bayer and the three lots the company wants held until further notice. 

 Update, 17 October 2003FDA corrected itself yesterday and reported that only four of the seven lots were being recalled by Bayer.

The company's newer i.v. immunoglobulin product, Gamunex, is not affected by the Oct. 3 notices.