Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
fentaNYL 100 mcg/50 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxygen
Reason cGMP Deviations
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 Terminated
Extended Phenytoin Sodium Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
Tiglutik
Reason Failed Viscosity Specifications: Out-of-specification test results for viscosity
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 Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.