Drug and supplement enforcement actions from the FDA, plus recalls for cosmetics and personal-care products. Data comes straight from official CPSC, FDA and USDA feeds and refreshes every six hours.
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The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
Cross Contamination with Other Products
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Presence of Particulate matter.
Label does not declare walnuts in English
Label does not declare walnuts in English
Label does not declare walnuts in English
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
CGMP deviations: tablets with black specks.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Presence of particulate matter: glass and stopper piece
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Failed Dissolution Specifications
Failed content uniformity specifications.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts, posing a deadly choking hazard.
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Lack of assurance of sterility. The recall is due to potential contamination