💊 Drugs Class I - Dangerous
Lack of Processing Controls.
All Recalls
95,102 total recalls in our database
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
💊 Drugs Class I - Dangerous
Lack of Processing Controls.
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.