ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
All Recalls
95,025 total recalls in our database
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
💊 Drugs Class I - Dangerous
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
First Royal Care Co. LLC
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
🏥 Medical Devices Class I - Dangerous
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Two devices were labeled with the same serial number
Bivona Aire-Cuf Endotracheal Tube
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Holes in product packaging impacts package integrity and may compromise sterility.
RAPTAR Laser Range Finders
Potomac River Group
🏥 Medical Devices Class I - Dangerous
RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
🏥 Medical Devices Class I - Dangerous
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.