Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cevimeline Hydrochloride Capsules
Failed Stability Specifications: product may not meet specification limit for assay test.
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