Class II · Moderate risk Ongoing
Nystatin 500 Mu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Nystatin 5bu
Reason Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk Ongoing
KinderMed INFANTS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
KinderMed KIDS' PAIN & FEVER Acetaminophen
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Naproxen Tablets
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Ongoing
Indomethacin 25mg Capsules
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Ongoing
Trospium Chloride Extended-Release Capsules
Reason Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Ongoing
Equate Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
DOP Instant Hand Sanitizer
Reason Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Class II · Moderate risk Ongoing
Deferasirox Tablets for Oral Suspension
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Certain Over-The-Counter
Reason CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Gynazole-1
Reason Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk Ongoing
Triamcinolone Acetonide Injectable Suspension
Reason Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Class II · Moderate risk Ongoing
octiq Lubricating Eye Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TRP Natural Eyes
Reason Lack of Assurance of Sterility