14,450 recalls · Class II, newest first
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Reason GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Reason 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.
Reason CGMP Deviations
Reason Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Reason Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Reason Lack of Assurance of Sterility
Reason Defective Container: Carton is missing the tablet blister strip and tablet.
Reason CGMP Deviations: Lack of quality assurance at the API manufacturer.
Reason 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.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason Failed Dissolution Specifications: out of specification results observed for low dissolution.
Reason GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Reason Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Reason Lack of assurance of sterility: Product bags leaking at seam.
Reason Lack of assurance of sterility: Product bags leaking at seam.
Reason Lack of assurance of sterility: Product bags leaking at seam.
Reason Lack of assurance of sterility: Product bags leaking at seam.
Reason Lack of assurance of sterility: Product bags leaking at seam.