Complete FDA and NHTSA recall records dated in November 2020.
These records include useful source details for the selected month.
Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and…
Potential Foreign Material
Stabilizer was made with Citric Acid instead of Sodium Citrate.
Stabilizer was made with Citric Acid instead of Sodium Citrate.
Undeclared Wheat and Milk.
Firm was notified by supplier of Elder Berries of a recall due to potential Salmonella contamination.
Processing error resulting in mixing of pasteurized and raw cider into final product.
GMP Deviations
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
GMP Deviations
Failed Dissolution Specifications: Out of specification for dissolution.
Labeling: Product Contains Undeclared API; Incorrect formulation
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were…
General Motors LLC (GM) is recalling certain 2021 Chevrolet Suburban and Tahoe and GMC Yukon and Yukon XL vehicles. During general assembly, a repair involved removal of one or both front…
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2020-2021 Toyota Avalon and 2020 Avalon Hybrid, RAV4, and RAV4 Hybrid vehicles. Breakaway pins within the steering…
Ford Motor Company (Ford) is recalling certain 2020 Explorer vehicles equipped with 2.3L engines and 19 gallon fuel tanks. The fuel tank inlet check valve may not be fully welded to the…
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
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.
