💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
All Recalls
95,083 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Pacific Medical Solutions
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled and found to contain variovorax paradoxus.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
💊 Drugs Class I - Dangerous
Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.
💊 Drugs Class I - Dangerous
cGMP deviations - presence of rubber particles found loose in the bulk product.
💊 Drugs Class I - Dangerous
Failed dissolution specifications - low dissolution results at S3 stage.
💊 Drugs Class I - Dangerous
Lack of assurance of sterility
💊 Drugs Class I - Dangerous
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
💊 Drugs Class I - Dangerous
Failed dissolution specifications - low dissolution results at S3 stage.
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
Mylan Pharmaceuticals
💊 Drugs Class I - Dangerous
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
🏥 Medical Devices Class I - Dangerous
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Nasal Pack, part number PSS2186
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
🏥 Medical Devices Class I - Dangerous
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
Upper Torso Tray, part number PSS1554(B
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
General Surgery Pack, part number PSS1380(A
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Minor/General/Ortho Pack, part number PSS3258(B
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Surgical Pack, part number PSS3540(A
Windstone Medical Packaging
🏥 Medical Devices Class I - Dangerous
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.