💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
All Recalls
95,114 total recalls in our database
Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
Sagent Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
Sagent Pharmaceuticals
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
Subpotent Drug
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Qualitest Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed tablet specifications: One lot was found to contain oversized tablets.
💊 Drugs Class I - Dangerous
Labeling: Illegible label. Writing is rubbing off of labels.
💊 Drugs Class I - Dangerous
Subpotent Drug
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Halyard Health
🏥 Medical Devices Class I - Dangerous
Defect: A hole or crack was found which may cause air to leak.
🏥 Medical Devices Class I - Dangerous
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
Arjo Hospital Equipment AB
🏥 Medical Devices Class I - Dangerous
The recalled devices labeling and instructions for use contain unapproved medical claims.
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Halyard Health
🏥 Medical Devices Class I - Dangerous
Defect: A hole or crack was found which may cause air to leak.
🏥 Medical Devices Class I - Dangerous
The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
🏥 Medical Devices Class I - Dangerous
One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
🏥 Medical Devices Class I - Dangerous
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.