May 2018 FDA Recall Scopolamine Transdermal System by L. Perrigo Company
D-0816-2018 - Defective delivery system

This Class II drug recall was voluntarily initiated by L. Perrigo Company on May 11, 2018 for the product Scopolamine Transdermal System. 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-0816-2018

Reason for Recall
Defective delivery system
Initiated
05-11-2018
Reported
05-23-2018
Quantity
569,520 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80041
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
L. Perrigo Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the product.
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010

Batch or Lot Expiration Information

Lot# : a) 46397, 46457 Exp 03/19; 46621, Exp 04/19; 46894, 46904, 46905, Exp 06/19; 47133, Exp 07/19; 47153, Exp 08/19; 47154, 47213, 47214, Exp 09/19; b) 46695, Exp 04/19; 46994, 47012, Exp 07/19; 47322 10/19; c) 46822, Exp 05/19 ; 47155, 47212, Exp 09/19

Affected Packages Involved in this Recall

45802-580-84 Scopolamine Transdermal System
45802-580-46 Scopolamine Transdermal System
45802-580-62 Scopolamine Transdermal System
45802-580-01 Scopolamine Transdermal System