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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 261–280 of 1,000 recalls

Class IIITerminated

Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42

Washington Homeopathic Products, Inc.

An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

March 18, 2021 · DrugView details →

Class IIITerminated

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.

Cardinal Health Inc.

Temperature Abuse

March 9, 2021 · DrugView details →

Class IIITerminated

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

Teva Pharmaceuticals USA

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

March 4, 2021 · DrugView details →

Class IIITerminated

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc

Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

March 2, 2021 · DrugView details →

Class IIITerminated

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96

SUN PHARMACEUTICAL INDUSTRIES INC

Subpotent

February 22, 2021 · DrugView details →

Class IIITerminated

Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03

Jubilant Cadista Pharmaceuticals, Inc.

Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

February 19, 2021 · DrugView details →

Class IIITerminated

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

February 19, 2021 · DrugView details →

Class IIITerminated

Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05

Edge Pharma, LLC

Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions

February 17, 2021 · DrugView details →

Class IIITerminated

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurity/Degradation Specifications

February 5, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51

Teligent Pharma, Inc.

Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.

February 2, 2021 · DrugView details →

Class IIITerminated

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Failed Dissolution Specifications

January 29, 2021 · DrugView details →

Class IIITerminated

Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)

Accord Healthcare, Inc.

Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials

January 28, 2021 · DrugView details →

Class IIITerminated

Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

January 21, 2021 · DrugView details →

Class IIITerminated

Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50

Calvin Scott & Company, Inc.

Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

January 15, 2021 · DrugView details →

Class IIITerminated

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40

SUN PHARMACEUTICAL INDUSTRIES INC

Incorrect Labeling: Incorrect lot number on secondary packaging

January 11, 2021 · DrugView details →

Class IIITerminated

Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

January 7, 2021 · DrugView details →

Class IIITerminated

Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05

Bausch Health Companies, Inc.

Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.

January 7, 2021 · DrugView details →

Class IIITerminated

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)

Genus Lifesciences Inc.

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

December 23, 2020 · DrugView details →

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