Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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Class II · Moderate risk Ongoing
Irbesartan Tablets USP
Reason Out of Specification for Dissolution
Class II · Moderate risk Ongoing
Inflectra
Reason cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Class III · Low risk Terminated
Badger 50
Reason Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class III · Low risk Completed
Venlafaxine Extended-Release Tablets
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Class II · Moderate risk Ongoing
Granix
Reason Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Class II · Moderate risk Ongoing
babyganics
Reason Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Class III · Low risk Terminated
Guaifenesin and Codeine Phosphate Oral Solution USP
Reason Superpotent; sodium benzoate preservative
Class II · Moderate risk Ongoing
Clobazam Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 20 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP 30 mg
Reason CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk Ongoing
Progesterone Injection USP
Reason Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class I · High risk Ongoing
Prograf
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk Ongoing
Astagraf XL
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk Ongoing
First Aid Beauty Ultra Repair Cream
Reason CGMP Deviations; product intended for quarantine was inadvertently distributed
Class II · Moderate risk Terminated
Cardura XL
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II · Moderate risk Terminated
Cardura XL
Reason Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class I · High risk Ongoing
Adrenalin Chloride Solution
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets
Reason Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class III · Low risk Ongoing
Methadone Hydrochloride Tablets
Reason Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class II · Moderate risk Terminated
phenylephrine in 0.9% Sodium Chloride Inj
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Class II · Moderate risk Terminated
ketamine inj 50 mg per 1 mL
Reason Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.