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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 11941–11960 of 17,816 recalls

Class IIITerminated

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

Lupin Pharmaceuticals Inc.

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

March 11, 2016 · DrugView details →

Class ITerminated

Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03

Teva Pharmaceuticals USA

Presence of Particulate Matter: particulate matter identified as glass in one vial.

March 9, 2016 · Drug

View details →

Class IITerminated

Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5

Hospira Inc.

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

March 8, 2016 · DrugView details →

Class IITerminated

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52

Dr. Reddy's Laboratories, Inc.

Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial

March 3, 2016 · DrugView details →

Class IITerminated

Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82

Sagent Pharmaceuticals Inc

Cross contamination with other products: metronidazole

March 1, 2016 · DrugView details →

Class IIITerminated

col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.

Allegiant Health

Superpotent Drug: High out of specification results for assay at the 6 month time point interval.

February 29, 2016 · DrugView details →

Class IIITerminated

Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.

Torrent Pharmaceuticals Limited

Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.

February 25, 2016 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09

Lupin Limited

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

February 19, 2016 · DrugView details →

Class IIITerminated

Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03

Lupin Limited

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

February 19, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.

Actavis Elizabeth LLC

Failed Impurities/Degradation Specifications: Out of specification for impurities.

February 16, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.

Actavis Elizabeth LLC

Failed Impurities/Degradation Specifications: Out of specification for impurities.

February 16, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.

Actavis Elizabeth LLC

Failed Impurities/Degradation Specifications: Out of specification for impurities.

February 16, 2016 · DrugView details →

Class IITerminated

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.

Actavis Elizabeth LLC

Failed Impurities/Degradation Specifications: Out of specification for impurities.

February 16, 2016 · DrugView details →

Class IITerminated

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.

Genzyme Corporation

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

February 16, 2016 · DrugView details →

Class IITerminated

Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.

Genzyme Corporation

Presence of Particulate Matter: Glass particles found in the product after reconstitution.

February 16, 2016 · DrugView details →

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