Padagis US LLC: Drug Recall

Recall #D-0372-2022 · 12/27/2021

Class II: Risk

Recall Details

Recall Number: D-0372-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Padagis US LLC
Status: Terminated
Date Initiated: 12/27/2021
Location: Minneapolis, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,868 bottles

Reason for Recall

Defective Delivery System

Product Description

Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02

Distribution Pattern

Nationwide USA

Other Recalls by Padagis US LLC

Class II: Risk 02/06/2025

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Class III: Low Risk 10/11/2024

Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II: Risk 11/01/2023

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II: Risk 09/28/2023

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class III: Low Risk 02/21/2023

Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.

View all recalls by Padagis US LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.