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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 5081–5100 of 17,755 recalls

Class IITerminated

Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (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

Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. 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

FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; 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

ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; 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

Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

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