Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle recall — FDA D-0804-2026
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lack of Assurance of Sterility
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
CGMP Deviations:Noted during FDA inspection
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
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