The FINANCIAL — Merck (known as MSD outside the United States and Canada) has become aware of the market recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by the Triad Group in the United States.
The Triad Group recall impacts the alcohol prep pads that are co-packaged and distributed with the Merck medicines PEGINTRON (peginterferon alfa-2b) single dose RediPen and PEGINTRON vials for markets in Europe, Asia Pacific (excluding Japan), Latin America (excluding Brazil) and Canada, and INTRON A (interferon alfa-2b) Multidose RediPen and INTRON A Solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America (excluding Brazil). Merck medicines distributed in the United States are not impacted by the Triad Group recall.
According to information posted on the Food and Drug Administration's (FDA) Medwatch website, http://www.fda.gov/Safety/MedWatch/default.htm, the recall was initiated by the Triad Group due to concerns about potential contamination of the products with the bacteria, Bacillus cereus. According to the FDA communication, use of the contaminated alcohol pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infection especially in at-risk populations, including immune-suppressed and surgical patients.
It is important to note that the Merck medicines are not contaminated, and should continue to be used in accordance with the package insert, and as directed by a healthcare provider, except the alcohol prep pad should be discarded. Patients and healthcare providers should use an alternate alcohol prep pad that is not involved with the recall, or alternatively use a sterile gauze pad in conjunction with isopropyl alcohol.
Upon discussion and agreement with local Ministries of Health, Merck will begin packaging orders without alcohol prep pads until a suitable alternative has been identified.
Merck will inform Healthcare Professionals in the impacted markets of the potential contamination of the alcohol swabs and ask them to immediately discontinue use. Merck will also provide them with information they can use to educate patients on the issue. Similar information will be provided by Merck to investigators of any affected ongoing clinical trials and to the regulatory agencies in the countries where the studies are underway.
Patients should consult their healthcare provider with any questions. Healthcare professionals may contact the local MSD office for additional information. Further information about the Triad Group recall can be found on the FDA website.
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