| Jan 10, 2024 |
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... |
Lack of Sterility Assurance: Aseptic process simulation failure. |
Class II |
BE PHARMACEUTICALS AG |
| Dec 28, 2023 |
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... |
Lack of Sterility Assurance |
Class II |
Fresenius Medical Care Holdings, Inc. |
| Nov 22, 2023 |
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... |
Lack of assurance of sterility. |
Class II |
Wells Pharma of Houston LLC |
| Nov 13, 2023 |
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL ... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), pa... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL ... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) pack... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) ... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ ... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Prop... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, T... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydro... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), pa... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%),... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 13, 2023 |
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL O... |
Non-Sterility |
Class I |
Kilitch Healthcare India Limited |
| Nov 9, 2023 |
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |
| Nov 9, 2023 |
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... |
Lack of Assurance of Sterility |
Class II |
SCA Pharmaceuticals, LLC |