Class II · Moderate risk Terminated
ePHEDrine Sulfate
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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Class II · Moderate risk Terminated
Buffered Lidocaine HCl
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Atropine Sulfate Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg
Reason Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II · Moderate risk Terminated
Ascend Laboratories
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Ascend Laboratories
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Dexamethasone - Moxifloxacin PF Injection
Reason Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Class III · Low risk Terminated
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Reason Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class II · Moderate risk Terminated
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only
Reason Subpotent drug.
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
Reason cGMP deviations: Vials may not be sealed correctly affecting sterility.
Class II · Moderate risk Terminated
Sensorcaine-MPF
Reason Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class II · Moderate risk Terminated
Hydroxyzine Hydrochloride Oral Solution
Reason Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk Terminated
Auryxia
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vumerity
Reason Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class II · Moderate risk Terminated
Docetaxel Injection USP 160 mg/8mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 400 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Imatinib Mesylate Tablets 100 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Busulfan Injection 60 mg/10 mL
Reason CGMP Deviations
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class I · High risk Terminated
TraZODONE Hydrochloride Tablets USP 100 mg
Reason Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.