September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -13
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
Professional Disposables International, Inc recalls PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc.,
Hazard: SubPotent: Out of Specification
September 1, 2021DrugsFDA
XELLIA PHARMACEUTICALS USA, LLC recalls Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured f
Hazard: 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.
September 1, 2021DrugsFDA
XELLIA PHARMACEUTICALS USA, LLC recalls Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured fo
Hazard: 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.
September 1, 2021DrugsFDA
ANHUI WELCOME FOREIGN TRADE CO.,LTD. recalls Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Ch
Hazard: Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
September 1, 2021DrugsFDA
RemedyRepack Inc. recalls Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repac
Hazard: A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
August 25, 2021DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed
Hazard: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
August 25, 2021DrugsFDA
Teligent Pharma, Inc. recalls Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52
Hazard: Correct Labeled Product Mispack
August 25, 2021DrugsFDA
Teligent Pharma, Inc. recalls Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-0
Hazard: Correct Labeled Product Mispack
August 25, 2021DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam Distr
Hazard: Failed Tablet/Capsule Specification: Some tablets are shaved
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Me
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceutic
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvi
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 1
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), an
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx on
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine,
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals US
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-0
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 194
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Ir
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-29
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wa
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. Nor
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), an
Hazard: Lack of Assurance of Sterility