February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rit
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distr
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Ai
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by:
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Hea
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health D
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL O
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL O
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bott
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby L
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (ND
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single P
Hazard: Non-Sterility
February 14, 2024DrugsFDA
Kilitch Healthcare India Limited recalls CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Sing
Hazard: Non-Sterility
February 14, 2024DrugsFDA
OMEZA LLC recalls Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Hazard: CGMP Deviations
February 14, 2024DrugsFDA
OMEZA LLC recalls Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Hazard: CGMP Deviations
February 7, 2024DrugsFDA
Azurity Pharmaceuticals, Inc. recalls Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals,
Hazard: Labeling: Label Mix-up
February 7, 2024DrugsFDA
Den-Mat Holdings, LLC recalls Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bot
Hazard: CGMP Deviations: products may not conform to the labeled specifications.
February 7, 2024DrugsFDA
Den-Mat Holdings, LLC recalls OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den
Hazard: CGMP Deviations: products may not conform to the labeled specifications.
February 7, 2024DrugsFDA
Amerisource Health Services LLC recalls Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Pack
Hazard: Failed Impurities/Degradation Specification.
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Marylan
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark B
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.