Bayer instructed patients to immediately discontinue use of the Triad alcohol prep pads included in Betaseron (interferon beta 1-b) packaging and to dispose of those pads in the trash.
Bayer instructed patients to immediately discontinue use of the Triad alcohol prep pads included in Betaseron (interferon beta 1-b) packaging and to dispose of those pads in the trash. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus.
This recall involved those products marked as sterile as well as nonsterile products. There was no involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging.
Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune-suppressed and surgical patients, warned FDA communication.
FDA recommended that if consumers have any of these types of products in their possession listing “Triad Group” as the manufacturer, they should refrain from using the products and return them to the place of purchase for a full refund.
To report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program, either complete and submit the report online at www.fda.gov/MedWatch/report.htm; call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form; or submit by fax to 1-800-FDA-0178.