Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.
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.
Family Dollar Stores
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class I - Dangerous
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
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
Teva Pharmaceuticals USA
Class I - Dangerous
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.
Class I - Dangerous
Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol
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.
Family Dollar Stores
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class I - Dangerous
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
Family Dollar Stores
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.
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.
Family Dollar Stores
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class I - Dangerous
cGMP deviation: Product held outside of appropriate temperature storage conditions.