🍔 Food 💊 Drugs 🏥 Medical Devices
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73. Class I

Reason: Microbial Contamination of Non-Sterile Products

Plastikon Healthcare LLC 20220607 Terminated
Distributed: Distributed Nationwide in the USA
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Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36. Class II

Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Padagis US LLC 20220817 Terminated
Distributed: Nationwide in the USA
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Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765. Class II

Reason: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Tsm Brands LLC 20220719 Ongoing
Distributed: Distributed in VA, USA
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Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734. Class II

Reason: Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol

Tsm Brands LLC 20220719 Ongoing
Distributed: Distributed in VA, USA
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Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01 Class II

Reason: CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

Teva Pharmaceuticals USA Inc 20220823 Terminated
Distributed: Nationwide within the United States
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Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4. Class III

Reason: Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

LNK International, Inc. 20220804 Terminated
Distributed: Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
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Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24 Class III

Reason: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Akorn, Inc 20220808 Ongoing
Distributed: Distributed Nationwide in the USA
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Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A. Class II

Reason: cGMP deviation: Product held outside of appropriate temperature storage conditions.

Family Dollar Stores, Llc. 20220810 Ongoing
Distributed: Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
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Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Class II

Reason: cGMP deviation: Product held outside of appropriate temperature storage conditions.

Family Dollar Stores, Llc. 20220810 Ongoing
Distributed: Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
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Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Class II

Reason: cGMP deviation: Product held outside of appropriate temperature storage conditions.

Family Dollar Stores, Llc. 20220810 Ongoing
Distributed: Distributed Nationwide in the USA to the following States: AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, UT
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