411 recalls · Class II, newest first
Reason Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Reason Presence of foreign substance.
Reason Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Reason Subpotent Drug
Reason Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason CGMP Deviations
Reason CGMP Deviations
Reason Failed Content Uniformity Specifications
Reason Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Reason cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason CGMP Deviations
Reason Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Reason Lack of Assurance of Sterility: Leaking vials
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Reason Discoloration: Brownish tablets
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Reason Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason Lack of Assurance of Sterility: Complaints of syringe breakage
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility