Class III · Low risk Terminated
Dr. Reddys
Reason Failed Dissolution Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Kroger
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rite Aid Pharmacy
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Rugby
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Wal-Fex D
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets
Reason Complaint received of foreign matter (metal) embedded in tablet.
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.
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 II · Moderate risk Ongoing
Medroxyprogesterone Acetate Injection
Reason Lack of Assurance of Sterility
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 Ongoing
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM…
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk Terminated
Trypan Blue 0.03%
Reason CGMP Deviations