DrugMay 5, 2021
Losartan Potassium USP, 50 mg recall — FDA D-0341-2021
CGMP deviation: Product found to contain trace amounts of NMBA
Class IIFDA: TerminatedPD-Rx Pharmaceuticals, Inc.
Latest records
Latest recalls — page 877
The newest recall records with useful source details are listed here.
DrugMay 5, 2021
Teligent Pharma Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recall — FDA D-0340-2021
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Class IIIFDA: TerminatedTeligent Pharma, Inc.
DrugMay 5, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and recall — FDA D-0348-2021
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus…
Class IIFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and recall — FDA D-0344-2021
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CareFusion 213 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0350-2021
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of…
Class IIFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0343-2021
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of…
Class IFDA: TerminatedCareFusion 213, LLC
DrugMay 5, 2021
Namoo Enterprise PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box recall — FDA D-0351-2021
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class IIFDA: TerminatedNamoo Enterprise LLC
DrugMay 5, 2021
Na Na Collection Triple SupremeZen Gold 3500 recall — FDA D-0354-2021
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class IIFDA: OngoingNa Na Collection
DrugMay 5, 2021
Genentech Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume recall — FDA D-0357-2021
Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in…
Class IIIFDA: TerminatedGenentech Inc.
DrugMay 5, 2021
Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 recall — FDA D-0342-2021
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test…
Class IIFDA: OngoingPreferred Pharmaceuticals, Inc.
DrugMay 5, 2021
CareFusion 213 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0345-2021
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of…
Class IFDA: TerminatedCareFusion 213, LLC
VehicleMay 5, 2021
Explorer body recall — NHTSA campaign 21V316000
Ford Motor Company (Ford) is recalling certain 2016-2019 Explorer vehicles. The retention pins could loosen and allow the roof rail covers to detach from the vehicle.
bodyFord Motor Company
VehicleMay 3, 2021
Santa Fe hoses, lines/piping, and fittings recall — NHTSA campaign 21V308000
Hyundai Motor America (Hyundai) is recalling certain 2021 Santa Fe vehicles equipped with 2.5-litre Turbo engines. The fuel pipe connecting the high pressure fuel pump to the fuel rail may…
hoses, lines/piping, and fittingsHyundai Motor America
Medical DeviceApr 28, 2021
Smiths Medical ASD Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring recall — FDA Z-1471-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended recall — FDA Z-1450-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage recall — FDA Z-1453-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
AZURE BIOTECH Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label recall — FDA Z-1432-2021
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
Class IIFDA: TerminatedAZURE BIOTECH Inc.
Medical DeviceApr 28, 2021
BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage recall — FDA Z-1459-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage recall — FDA Z-1457-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage recall — FDA Z-1463-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage recall — FDA Z-1460-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage recall — FDA Z-1462-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage recall — FDA Z-1446-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
Welch Allyn Inc Mortara ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory recall — FDA Z-1483-2021
Devices do not meet IEC 60601-2-27 requirements as labeled.
Class IIFDA: TerminatedWelch Allyn Inc Mortara
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