PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 23, 2018 Initiated: May 11, 2018 #D-0816-2018

Product Description

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

Details

Recalling Firm
L. Perrigo Company
Units Affected
569,520 cartons
Distribution
Nationwide in the U.S.A.
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by L. Perrigo Company. Units affected: 569,520 cartons.
Why was this product recalled?
Defective delivery system
Which agency issued this recall?
This recall was issued by the FDA Drug on May 23, 2018. Severity: Moderate. Recall number: D-0816-2018.