- September 25, 2002, PRESS RELEASE
RESEARCH TRIANGLE PARK, NC, USA—Bayer Biological Products (BP) reports this month it introduces seal tabs on all boxes containing Gamimune N, Immune Globuline Intravenous (Human), 10 percent Solvent/Detergent Treated. With the announcement of this innovation, says the manufacturer, Bayer BP becomes the first company in the biological products industry to introduce enhanced tamper-resistant packaging in response to recent concerns about product tampering.
According to Bayer BP, the new packaging is designed to help health-care professionals and patients detect if the product has been compromised by a third party. "The packging features seal tabs on the outside of the box containing the product. Any disruption in the sealed tabs will signal to users that product integrity may be compromised, and therefore, the product should not be used," adds co.
The move to introduce the enhanced tamper-resistant packaging is in response to what the company calls "apparent tampering." According to Bayer BP, the company uncovered tampering with Gamimune N Immune Globulin Intravenous (Human) 10%, Solvent/Detergent Treated. "Based on a single customer report describing the presence of white precipitate in the solution, Bayer, is, as a precautionary measure, initiating a voluntary recall of lot #648X062. Recently, Bayer initiated [a separate] recall of lot #648X078 because of a similar report of a white precipitate in the solution."
More information is available at bayerbiologicals.com.