💊 Drugs Class I - Dangerous
Underfilled units.
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
💊 Drugs Class I - Dangerous
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Atlantic Management Resources
💊 Drugs Class I - Dangerous
cGMP Deviations
💊 Drugs Class I - Dangerous
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
Atlantic Management Resources
💊 Drugs Class I - Dangerous
cGMP Deviations
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Atlantic Management Resources
💊 Drugs Class I - Dangerous
cGMP Deviations
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal MYELOGRAM PACK, REF 89-9304.05
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
DeRoyal VIT RD PACK 86ST, REF 89-7308.09
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
DeRoyal FOOT PACK, REF 89-9252.08
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
DeRoyal PAIN TRAY, REF 89-10464.03
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
XXX
HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
Stradis Medical, LLC
🏥 Medical Devices Class I - Dangerous
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.