💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
All Recalls
95,102 total recalls in our database
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
Church & Dwight
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
💊 Drugs Class I - Dangerous
Failed Impurity/Degradation Specifications
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
Orient Pharma Co., Ltd. Yunlin Plant
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications.
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Church & Dwight
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
💊 Drugs Class I - Dangerous
Defective container; blister packaging inadequately sealed.
Philips eL18-4 EMT Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
🏥 Medical Devices Class I - Dangerous
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
Philips C9-5EC Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
🏥 Medical Devices Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
🏥 Medical Devices Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
🏥 Medical Devices Class I - Dangerous
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
Philips eL18-4 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
🏥 Medical Devices Class I - Dangerous
Cather packaging may contain the incorrect French size.
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Philips Respironics
🏥 Medical Devices Class I - Dangerous
This device does not indicate for use in patients with respiratory failure.
Philips C5-2 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips L12-3 Transducer.
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.