Complete FDA and NHTSA recall records dated in June 2020.
These records include useful source details for the selected month.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2019-2020 RAV4 and 2020 RAV4 Hybrid vehicles equipped with electric power steering (EPS). Water may enter through the…
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use…
Distributed to the field without having completed design history files or design transfer activities
There is potential for the plastic optical tip to become detached from the metal shaft.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Distributed to the field without having completed design history files or design transfer activities
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring…
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in…
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Distributed to the field without having completed design history files or design transfer activities
Distributed to the field without having completed design history files or design transfer activities
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of…
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
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.
