Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-09-01FDA-DrugProfessional Disposables International, IncClass IIPDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,
SubPotent: Out of Specification
- 2021-09-01FDA-DrugXELLIA PHARMACEUTICALS USA, LLCClass IIMicafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- 2021-09-01FDA-DrugXELLIA PHARMACEUTICALS USA, LLCClass IIMicafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- 2021-09-01FDA-DrugANHUI WELCOME FOREIGN TRADE CO.,LTD.Class IIPi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
- 2021-09-01FDA-DrugRemedyRepack Inc.Class IICarvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
- 2021-08-25FDA-DrugZydus Pharmaceuticals (USA) IncClass IICarvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
- 2021-08-25FDA-DrugTeligent Pharma, Inc.Class IITriamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.
Correct Labeled Product Mispack
- 2021-08-25FDA-DrugTeligent Pharma, Inc.Class IIEconazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Correct Labeled Product Mispack
- 2021-08-25FDA-DrugDr. Reddy's Laboratories, Inc.Class IITizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
Failed Tablet/Capsule Specification: Some tablets are shaved
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAdenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMethylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAlprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMetoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAdenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IINorepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIEpoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIVecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIIdarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIHaloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMethylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIDAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugSpirit PharmaceuticalsClass IIAcetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
cGMP deviations: Discolored acetaminophen
- 2021-08-25FDA-DrugDuPont Nutrition USA, IncClass IIIAvicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Out of specification results for conductivity.
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