🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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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 02895. NDC 76168-712-10 Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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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 Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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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), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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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 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017 Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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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 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. Class I

Reason: Non-Sterility

Kilitch Healthcare India Limited 20231113 Ongoing
Distributed: Nationwide within the United States
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Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials Class II

Reason: CGMP Deviations

OMEZA LLC 20240119 Terminated
Distributed: US Nationwide
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Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS Class II

Reason: CGMP Deviations

OMEZA LLC 20240119 Terminated
Distributed: US Nationwide
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Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03 Class I

Reason: Labeling: Label Mix-up

Azurity Pharmaceuticals, Inc. 20240104 Terminated
Distributed: USA nationwide
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Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436. Class II

Reason: CGMP Deviations: products may not conform to the labeled specifications.

Den-Mat Holdings, LLC 20240116 Ongoing
Distributed: Nationwide in the US
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