The US Food and Drug Administration (FDA) announced that Mylan Institutional Business voluntarily initiated a recall of specific lots of injectable products. Mylan is a global pharmaceutical company and stated that the products are being recalled because of a visible presence of foreign particulate matter observed during retention testing.
The injectable products affected are:
For exact lot numbers, strengths, sizes, and expiration dates of the products recalled, please refer to:
http://www.fda.gov/Safety/Recalls/ucm444498.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Consumers who have bought the products listed in the website above are advised to stop using them and return them to the origin of purchase.
Mylan Institutional Business could be contacted Monday-Friday from 8.00am to 5.00pm (EST) at:
1-800-796-9526
customer.service@mylan.com
Particulate matter:
Particulate matter in injectable products could cause severe harm to users/patients and could be life-threatening. Some of the possible adverse effects are:
No adverse incidents have been reported to date. However, consumers are advised to contact their physician/hospital if they experience any problems associated with the injections.
Written by Mangala Sarkar Ph.D.
Primary Reference:
U.S. Food and Drug Administration. (n.d.). Retrieved April 24, 2015, from http://www.fda.gov/Safety/Recalls/ucm444498.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Additional Reference:
(n.d.). Retrieved April 24, 2015, from http://www.pda.org/docs/default-source/website-document-library/publications/industry-perspective-on-medical-risk-of-visible-particles-in-injectable-products.pdf?sfvrsn=2
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