411 recalls · Class II, newest first
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Reason Failed Impurities/Degradation Specifications: Out-of-specification test results.
Reason CGMP Deviations: Out of specification for residual solvents.
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason CGMP Deviations: potential presence of Burkholderia cepacia complex
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Reason Labeling: Incorrect or Missing Package Insert
Reason Subpotent Drug: Out of specification for assay
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations
Reason CGMP Deviations
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the…