Complete FDA and NHTSA recall records dated in March 2019.
These records include useful source details for the selected month.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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) was identified.
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
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…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
