Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0816-2018

May 11, 2018

Class II

Product summary

Firm
L. Perrigo Company
Event
Event 80041
Status
Terminated
Classification
Class II
Quantity
569,520 cartons
Official record key
drug-enforcement:D-0816-2018

Official wording

Reason: Defective delivery system

Code 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

Distribution pattern: Nationwide in the U.S.A.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective delivery system