Prescription and over-the-counter medications
Golden State Medical Supply
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Lack of Assurance of Sterility
Amerisource Health Services
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
ANI Pharmaceuticals
Defective Container; packets were found to be either empty or partially full.
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Lannett Company
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Haleon US Holdings
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Presence of a Foreign Substance; black particles observed in liquid
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Crystallization; identified as Buprenorphine free base
Failed Dissolution Specifications
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Lack of assurance of Sterility: potential product contamination
Lack of assurance of Sterility: potential product contamination
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Acella Pharmaceuticals
Chemical contamination; presence of lead and lithium above specification
JB Chemicals and Pharmaceuticals
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.