FDA recall D-0816-2018

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

Distribution

Nationwide in the U.S.A.

Key facts

Status

Terminated

Initiation date

2018-05-11

Report date

2018-05-23

Termination date

2020-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0816-2018