Class II · Moderate risk
Stage 2-Ophardt Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Avant Foaming Hand Sanitizer Ophardt
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Avant Foaming Hand Sanitizer
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Class II · Moderate risk
Fulvestrant Injection 250mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets
FAILED DISSOLUTION SPECIFICATIONS
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Ativan Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class II · Moderate risk
Naftifine Hydrochloride Gel
Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class II · Moderate risk
Aripiprazole Tablets
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Anticoagulant Sodium Citrate Solution
Lack of Assurance of Sterility
Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ropivacaine HCl 123 mg
Lack of Assurance of Sterility
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility