95,114 total recalls in our database
Lupin Pharmaceuticals
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lupin Pharmaceuticals
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Lupin Pharmaceuticals
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lupin Pharmaceuticals
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Presence of Particulate Matter: Identified as Glass Particles
Bryant Ranch Prepack, Inc.
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Lupin Pharmaceuticals
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
Karl Storz Endoscopy
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Jjgc Industria E Comercio De Materials Dentarios Sa
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
Siemens Healthcare Diagnostics
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Implant Direct Sybron Manufacturing
Packaged dental implant contains a different size then the size declared on the labeling.
FujiFilm Healthcare Americas
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.