Class II · Moderate risk
Cevimeline Hydrochloride Capsules
Failed Stability Specifications: product may not meet specification limit for assay test.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Bromfenac Ophthalmic Solution
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class II · Moderate risk
Mupirocin Calcium Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban (mupirocin calcium)
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class III · Low risk
Ampicillin Capsules
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class II · Moderate risk
Midazolam HCl Syrup
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class III · Low risk
Methocarbamol Tablets
Presence of Foreign Substance: Presence of hair.
Class II · Moderate risk
DuraPrep Surgical Solution Iodine Povacrylex
Chemical contamination: Product may be contaminated with a toxic compound.
Class I · High risk
KABOOM action strips
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Class I · High risk
LiDa DAIDAIHUA
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Class II · Moderate risk
Rivastigmine Tartrate Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Hydrochlorothiazide Tablet USP 25 mg
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Class II · Moderate risk
Lisinopril Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.