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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 6601–6620 of 17,773 recalls

Class IITerminated

Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075

Basic Reset Inc.

Marketed without an Approved NDA/ANDA

October 18, 2019 · DrugView details →

Class IIITerminated

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IIITerminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IITerminated

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

October 17, 2019 · DrugView details →

Class IITerminated

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

October 17, 2019 · DrugView details →

Class IIITerminated

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.

Sandoz Inc

Labeling: Incorrect or missing package insert.

October 17, 2019 · DrugView details →

Class IIITerminated

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

Amneal Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

October 16, 2019 · DrugView details →

Class IITerminated

Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

Class IITerminated

Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41.

8046255 Canada Inc. DBA Viatrexx

Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.

October 15, 2019 · DrugView details →

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