Class I - Dangerous
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class I - Dangerous
Lack of Assurance of Sterility
Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Neptune Resources
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Class I - Dangerous
CGMP Deviations
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Class I - Dangerous
Chemical Contamination; presence of benzene.
Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Neptune Resources
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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 (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis, MN 55403
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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 17011, NDC 11822-2254-3
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
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
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class I - Dangerous
CGMP Deviations
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 79903-168-01
Kilitch Healthcare India Limited
Class I - Dangerous
Non-Sterility