Merck & Co., Inc.
Overview
Merck & Co., Inc. is a global healthcare company that develops, manufactures, and markets medicines, vaccines, biologic therapies, and animal health products. With a commitment to scientific excellence, Merck is dedicated to improving health outcomes across diverse therapeutic areas.
Therapeutic areas
FDA compliance signals
10 FDA enforcement records linked to this company.
- recall — Class II2025-08-20
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
- 4832016-09-20
Late submission of 15-day report
- 4832016-09-20
Failure to develop written procedures
- recall — Class III2014-05-14
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- recall — Class III2014-05-14
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- recall — Class III2014-05-14
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- recall — Class III2014-05-14
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- 4832013-10-08
Late submission of 15-day report
- 4832013-10-08
Failure to develop written procedures
- warning_letter2012-02-17
FDA Warning Letter (drug product)
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