Class I - Dangerous
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80
Eli Lilly & Company
Class I - Dangerous
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class I - Dangerous
Labeling: Not elsewhere classified: Mislabeling
Micafungin 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
XELLIA PHARMACEUTICALS USA
Class I - Dangerous
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.
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
HIS ENTERPRISE
Class I - Dangerous
Marketed without ANDA/NDA approval
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
SigmaPharm Laboratories
Class I - Dangerous
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Micafungin 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
XELLIA PHARMACEUTICALS USA
Class I - Dangerous
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.
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Teligent Pharma
Class I - Dangerous
Defective container: possibility for lack of seal integrity.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
DAUNOrubicin 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
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Correct Labeled Product Mispack
Leucovorin 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
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Norepinephrine 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
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility
Tizanidine 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.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specification: Some tablets are shaved
Class I - Dangerous
Failed Stability Specifications; out of specification for shear.
Class I - Dangerous
Correct Labeled Product Mispack
Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Teva Pharmaceuticals USA
Class I - Dangerous
Lack of Assurance of Sterility