Home / Recalls / Padagis US LLC / D-0372-2022

D-0372-2022 Class II Terminated

Recalled by Padagis US LLC — Minneapolis, MN

Recall Details

Product Type
Drugs
Report Date
January 19, 2022
Initiation Date
December 27, 2021
Termination Date
September 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,868 bottles

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

Reason for Recall

Defective Delivery System

Distribution Pattern

Nationwide USA

Code Information

Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023

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  • D-0464-2023 Class III — Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl o (February 21, 2023)
  • D-1497-2022 Class II — Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Per (August 17, 2022)