11,818 recalls · Class II, newest first
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
CGMP Deviations
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Lack of Assurance of Sterility
Defective Container: Carton is missing the tablet blister strip and tablet.
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Lack of assurance of sterility: Product bags leaking at seam.
Presence of Foreign Substance: potential presence of plastic particles.