December 2021 FDA Recall Nitroglycerin Lingual by Padagis Us Llc
D-0372-2022 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Padagis Us Llc on December 27, 2021 for the product Nitroglycerin Lingual. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0372-2022
Defective Delivery System
12-27-2021
01-19-2022
11,868 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Padagis US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
09-28-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
