Prescription and over-the-counter medications
The Harvard Drug Group
Defective container; blister packaging inadequately sealed.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Church & Dwight
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Failed Impurity/Degradation Specifications
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Orient Pharma Co., Ltd. Yunlin Plant
Failed Impurities/Degradation Specifications.
Church & Dwight
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Defective container; blister packaging inadequately sealed.
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Presence of foreign tablets/capsules.
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Fresenius Medical Care Holdings
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Thrive Health and Wellness, LLC
Lack of Assurance of Sterility
Lack of Assurance of Sterility