🍔 Food 💊 Drugs 🏥 Medical Devices
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 Class II

Reason: 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.

MEDLINE INDUSTRIES, LP - Northfield 20240110 Ongoing
Distributed: Nationwide in the USA
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Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 Class II

Reason: CGMP Deviations

Amerisource Health Services LLC 20240125 Terminated
Distributed: USA Nationwide
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Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05 Class III

Reason: Misprint on tablet

Dr. Reddy's Laboratories, Inc. 20240118 Ongoing
Distributed: Nationwide
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Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01 Class III

Reason: Misprint on tablet

Dr. Reddy's Laboratories, Inc. 20240118 Ongoing
Distributed: Nationwide
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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 Class I

Reason: Non-Sterility

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

Reason: Non-Sterility

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

Reason: Non-Sterility

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

Reason: Non-Sterility

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

Reason: Non-Sterility

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

Reason: Non-Sterility

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