💊 Drugs Class I - Dangerous
CGMP Deviations: Potential risk of Cross Contamination
All Recalls
95,094 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential risk of Cross Contamination
Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
AVEVA Drug Delivery Systems
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
AVEVA Drug Delivery Systems
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
💊 Drugs Class I - Dangerous
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential risk of Cross Contamination
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential risk of Cross Contamination
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
Breckenridge Pharmaceutical
💊 Drugs Class I - Dangerous
CGMP Deviations: Potential risk of Cross Contamination
💊 Drugs Class I - Dangerous
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
🏥 Medical Devices Class I - Dangerous
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Limacorporate S.p.A
🏥 Medical Devices Class I - Dangerous
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.
🏥 Medical Devices Class I - Dangerous
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Fenwal
🏥 Medical Devices Class I - Dangerous
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
Synthes (USA) Products
🏥 Medical Devices Class I - Dangerous
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length