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.
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lack of Assurance of Sterility
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
Lack of Assurance of Sterility
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Lack of Assurance of Sterility
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Defective Container: Repetitive complaints received indicating pump not working.
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Tiguan LWB vehicles. The tire information label contains inaccurate tire dimension and inflation pressure…
Gulf States Toyota (GST) is recalling certain 2019 C-HR, 4Runner, Avalon, Avalon Hybrid, Camry, Camry Hybrid, Highlander, Land Cruiser, Prius, RAV4, Sequoia, Tacoma, Sienna, Tundra and…
Nissan North America, Inc. (Nissan) is recalling certain 2019 Nissan Altima vehicles. The brake switch bracket may be in the incorrect location, which may cause the brake switch to remain…
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label…
Potential esophageal laceration during a patient procedure
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the…
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the…
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label…
The sterile barrier may contain packaging seal defects.
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the…
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.
