Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Subpotent. drug
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Subpotent; Hydrochlorothiazide at the 9 month time point.
Presence of Precipitate; precipitation of drug product
Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen.
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.