Prescription and over-the-counter medications
Denver Solutions, LLC
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Efficient Laboratories
Microbial Contamination of Non-Sterile Products
Efficient Laboratories
Microbial Contamination of Non-Sterile Products
Efficient Laboratories
Microbial Contamination of Non-Sterile Products
Superpotent Drug
Superpotent; Hydrochlorothiazide
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Valgene Incorporated
Lack of Processing Controls
Superpotent Drug
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Valgene Incorporated
Lack of Processing Controls
Preferred Pharmaceuticals
Defective container: Out of specification for container integrity leading to bottles leaking.
Failed dissolution specifications
Product Mix-up
Failed dissolution specifications
Failed dissolution specifications
Crystallization: Product appears to be turbid.
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Dr. Reddy's Laboratories
Failed dissolution specifications
Failed dissolution specifications