Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Subpotent Drug: Heparin raw material was found to have low potency
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.