Class II · Moderate risk Terminated
Metformin 750 mg Extended Release NDC # 70518-2920-00
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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Class II · Moderate risk Terminated
Pioglitazone Tablets USP
Reason Superpotent and Failed Tablet/Capsule Specifications
Class II · Moderate risk Terminated
Cefixime 400 mg capsule
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Oxycodone Hydrochloride Tablets
Reason Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Nitroglycerin Lingual Spray
Reason Defective Delivery System
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution
Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Class I · High risk Terminated
SENNA Syrup
Reason Microbial Contamination of Non-Sterile Product
Class II · Moderate risk Terminated
Cefixime Capsules
Reason Failed impurities/degradation specifications
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Penicillin V Potassium for Oral Solution
Reason Subpotent
Class I · High risk Terminated
Clobetasol Propionate Ointment USP
Reason Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Class II · Moderate risk Terminated
Brinzolamide Ophthalmic Suspension
Reason Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Class II · Moderate risk Terminated
Diclofenac Sodium Topical Solution 1.5%
Reason Defective Container: Leaking containers.
Class II · Moderate risk Terminated
Trypan Blue 0.03%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vancomycin HCl Oral Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Tetracaine HCl Nasal Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Promethazine HCl Topical Ointment
Reason CGMP Deviations
Class II · Moderate risk Terminated
Vitamin K
Reason CGMP Deviations
Class II · Moderate risk Terminated
Lidocaine HCl/Phenylephrine HCl Nasal Solution
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenol
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound-PE Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound-PE Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Profound Dental Gel
Reason CGMP Deviations