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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 5701–5720 of 17,755 recalls

Class IITerminated

Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.

Keryx Biopharmaceuticals, Inc.

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

July 10, 2020 · DrugView details →
Class IITerminated

Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 54665 NDC 76753-001-01

Maquiladora Miniara Sa De Cv

CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.

July 9, 2020 · Drug
View details →
Class IITerminated

Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01

Lupin Pharmaceuticals Inc.

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 7, 2020 · DrugView details →
Class ITerminated

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

CareFusion 213, LLC

Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

July 7, 2020 · DrugView details →
Class IITerminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07

Lupin Pharmaceuticals Inc.

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 7, 2020 · DrugView details →
Class IITerminated

Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07

Lupin Pharmaceuticals Inc.

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 7, 2020 · DrugView details →
Class ITerminated

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

Mylan Institutional LLC

Presence of Particulate Matter

July 7, 2020 · DrugView details →
Class ITerminated

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400

CareFusion 213, LLC

Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

July 7, 2020 · DrugView details →
Class ITerminated

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

CareFusion 213, LLC

Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

July 7, 2020 · DrugView details →
Class IITerminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

Lupin Pharmaceuticals Inc.

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 7, 2020 · DrugView details →
Class ITerminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

CareFusion 213, LLC

Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

July 7, 2020 · DrugView details →
Class IIITerminated

Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Distributed in the U.S.A. by Allergan, Irvine, CA 92612, UPC 300234966005

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →
Class IIITerminated

Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

July 6, 2020 · DrugView details →
Class IIITerminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

SUN PHARMACEUTICAL INDUSTRIES INC

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

July 6, 2020 · DrugView details →
Class IIOngoing

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

Granules Pharmaceuticals Inc

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

July 3, 2020 · DrugView details →
Class IITerminated

Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →
Class IITerminated

Progesterone 150 mg Troche, 30 troches MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →
Class IITerminated

Progesterone 200 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →
Class IITerminated

Estriol 6 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →
Class IITerminated

Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →
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