Tris Pharma infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg recall — FDA D-0494-2019
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Complete FDA and NHTSA recall records dated in 2019, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled…
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Volkswagen Group of America, Inc. (Audi) is recalling certain 2019 Q7, Q8, S5 Cabriolet, and S5 Sportback vehicles. The front shock absorber forks may develop cracks allowing the shock…
Volkswagen Group of America (Volkswagen) is recalling certain 2019 Jetta vehicles. An incorrect driver frontal airbag may have been installed during a service/repair visit.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
potential for urine leakage around the vent on the vented sample port
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and…
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface…
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a…
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the…
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on…
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.