557 recalls, newest first
Reason Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
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 Dissolution Specifications
Reason Failed Dissolution Specifications
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 Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Reason Defective Container
Reason Defective Container
Reason Defective Container
Reason Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Reason CGMP Deviations
Reason Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
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 Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
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.