💊 Drugs Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
All Recalls
95,089 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
💊 Drugs Class I - Dangerous
cGMP deviations: Batch was released prior to approval.
💊 Drugs Class I - Dangerous
CGMP Deviations
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Inmar Supply Chain Solutions
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
💊 Drugs Class I - Dangerous
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
TMC Acquisitions LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
TMC Acquisitions LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility
💊 Drugs Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Subpotent: Out of Specification for Assay Test at the 3-month time point.
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
CGMP Deviations
💊 Drugs Class I - Dangerous
CGMP Deviations: Products not manufactured under current good manufacturing practices.
💊 Drugs Class I - Dangerous
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
🏥 Medical Devices Class I - Dangerous
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Boston Scientific
🏥 Medical Devices Class I - Dangerous
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.