Class II · Moderate risk Terminated
Divalproex Sodium Extended-Release Tablets
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP 25 mg 50 tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP 50 mg 50 tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class I · High risk Terminated
Titanium 4000
Reason Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Class III · Low risk Terminated
Fentanyl Citrate Injection
Reason Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Class II · Moderate risk Terminated
Unison Hand Care Products
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Sani-Guard-SF Waterless Foam Hand Sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Mild Health Care Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Antibacterial Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
INODERM Antiseptic Hand Soap
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Instant Waterless Hand Sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
AQUACIL instant foaming hand sanitizer
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as…
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Class II · Moderate risk Terminated
Losartan Potassium/HCTZ
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class III · Low risk Terminated
Carvedilol Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Class I · High risk Terminated
FENTANYL Transdermal System
Reason Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class II · Moderate risk Terminated
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal…
Reason Defective Delivery System: difficult to express
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.