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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 5381–5400 of 17,755 recalls

Class ITerminated

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

AVKARE Inc.

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

December 7, 2020 · DrugView details →

Class IITerminated

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

AVKARE Inc.

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

December 7, 2020 · DrugView details →

Class IITerminated

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17

Hikma Pharmaceuticals USA Inc.

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.

December 7, 2020 · DrugView details →

Class IITerminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications

December 3, 2020 · DrugView details →

Class IITerminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications

December 3, 2020 · DrugView details →

Class IIOngoing

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

cGMP deviations: Product made at the same facility where product tested was sub-potent.

December 1, 2020 · DrugView details →

Class IIOngoing

Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02

GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

cGMP deviations: Product made at the same facility where product tested was sub-potent.

December 1, 2020 · DrugView details →

Class IIOngoing

BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

Class IIOngoing

Pentosan Polysulfate, 300 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Advanced Nutriceuticals, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

November 30, 2020 · DrugView details →

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