Class II · Moderate risk
Sufentanil Citrate Injection
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Leader
Failed Dissolution Specifications
Class III · Low risk
CVS Health
Failed Dissolution Specifications
Class III · Low risk
Qc Quality Choice
Failed Dissolution Specifications
Class III · Low risk
equate
Failed Dissolution Specifications
Class III · Low risk
Dr. Reddys
Failed Dissolution Specifications
Class III · Low risk
Kroger
Failed Dissolution Specifications
Class III · Low risk
Rite Aid Pharmacy
Failed Dissolution Specifications
Class III · Low risk
Rugby
Failed Dissolution Specifications
Class III · Low risk
Wal-Fex D
Failed Dissolution Specifications
Class II · Moderate risk
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Lack of Assurance of Sterility
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL
Lack of Assurance of Sterility
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
Class II · Moderate risk
Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Pioglitazone Tablets USP
Superpotent and Failed Tablet/Capsule Specifications
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Class III · Low risk
Gatifloxacin Ophthalmic Solution
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
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
Class I · High risk
SENNA Syrup
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
Subpotent