Merck is pulling back its Liptruzet, or cholesterol drug product because of packaging problems that might hinder its power a press release on Fierce Pharma Manufacturing reported Tuesday.
"The recall will deplete all available supply in the U.S., and stock-outs are expected," Merck said in a statement. "The two active ingredients remain available: Zetia (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers," Merck said in a statement.
Air and moisture could seep through the product's laminate foil located on the outside of select products and decrease the medicine's forcefulness while also altering its composition the press release reported.
The recall affects products sent throughout the United States, and Puerto Rico the press release reported.
Merck is collaborating with the U.S. Food and Drug Administration on the recall notifying business to business distributors. The medicine is still being sold in pharmacies, and kept in patients hands the press release reported. Users can still take the quantities they have based on recommendations from their health care provider.
There is a slim possibility, the recall issue affects the product's safety, or anything related to a user's lipid information the press release reported.
Users who have reactions or issues to the product or issues with the product can contact Merck at 1-800-672-6372 Monday to Friday from 8 a.m. to 7 p.m. the press release reported. Those with questions should consult their health care provider the press release reported. They should also continue therapy until discussing discontinuing it with a doctor the press release reported.
Such users can also contact the United States Federal Drug Administration's MedWatch Adverse Event Reporting program on the internet, through the mail, or by fax the press release reported.
If through the mail, send an FDA 3500 form with postage paid, and addressed to the address on the form the press release reported. Users can find the form here. Faxes should be sent to 1-800-FDA-0178.
Merck pulled back some of its Gardasil HPV vaccine, three weeks ago over fear that 10 out of 743,360 containers contained glass particles the press release reported.
