Complete FDA and NHTSA recall records dated in 2020, 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.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Failed Stability Specifications: Below specification result for buprenorphine release rate.
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680…
Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result…
Unit boxes not properly sealed
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is…
Unit boxes not properly sealed
Unit boxes not properly sealed
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307…
LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to…
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.
