Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0089-1
Reason: Non-Sterility
D-0299-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1
Reason: Non-Sterility
D-0297-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC ...
Reason: Non-Sterility
D-0303-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5
Reason: Non-Sterility
D-0306-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite...
Reason: Non-Sterility
D-0309-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
Reason: Non-Sterility
D-0304-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
Reason: Non-Sterility
D-0301-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI ...
Reason: Non-Sterility
D-0294-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000...
Reason: Non-Sterility
D-0291-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1
Reason: Non-Sterility
D-0295-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI ...
Reason: Non-Sterility
D-0296-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 7616...
Reason: Non-Sterility
D-0298-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA ...
Reason: Non-Sterility
D-0308-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 7...
Reason: Non-Sterility
D-0290-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
Reason: Non-Sterility
D-0307-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
Reason: Non-Sterility
D-0311-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20)...
Reason: Non-Sterility
D-0292-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
Reason: Non-Sterility
D-0310-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
Reason: Non-Sterility
D-0302-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 7616...
Reason: Non-Sterility
D-0305-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (T...
Reason: Non-Sterility
D-0300-2024February 14, 2024Navi Mumbai
Kilitch Healthcare India Limited
Class IOngoing
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
Reason: Non-Sterility
D-0293-2024February 14, 2024Navi Mumbai
BE PHARMACEUTICALS AG
Class IITerminated
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 20...
Reason: Lack of Sterility Assurance: Aseptic process simulation failure.
D-0262-2024January 31, 2024Zug, N/A
Fresenius Medical Care Holdings, Inc.
Class IIOngoing
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Reason: Lack of Sterility Assurance
D-0218-2024January 10, 2024Waltham, MA
Wells Pharma of Houston LLC
Class IICompleted
ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10