Class II · Moderate risk
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 15 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Chlorpheniramine Maleate 4 mg tablets
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Sunitinib Malate Capsules
Labeling: Label Mix-Up
Class II · Moderate risk
Class II · Moderate risk
OneLAX Docusate Sodium Liquid
CGMP Deviations
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets 30 mg
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
Liceout
CGMP violations.
Class II · Moderate risk
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Class II · Moderate risk
Cisplatin Injection
Failed Impurities/Degradation Specifications.
Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
Class III · Low risk
Ciclopirox Gel 0.77%
Defective Container: Firm received complaints of broken tube at the seal.