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

FDA recall notice · announced May 23, 2018 · L. Perrigo

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Defective delivery system

Notes

Distribution: Nationwide in the U.S.A.
Lot/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
Quantity: 569,520 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0816-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.