💊 Drugs Class I - Dangerous
Lack of Processing Controls.
All Recalls
92,900 total recalls in our database
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
SUN PHARMACEUTICAL INDUSTRIES
💊 Drugs Class I - Dangerous
Presence of foreign substance: identified as aluminum.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Cardinal Health
💊 Drugs Class I - Dangerous
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Alembic Pharmaceuticals Limited
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Cardinal Health
💊 Drugs Class I - Dangerous
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Cardinal Health
💊 Drugs Class I - Dangerous
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
GYN ROBOTIC PACK. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
LAP CHOLE PACK. Medical convenience kit.
AVID Medical
🏥 Medical Devices Class I - Dangerous
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.