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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 5061–5080 of 17,755 recalls

Class IITerminated

Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

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