FDA recall D-0133-2017

Product

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054

Reason for recall

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Distribution

TN

Key facts

Status

Terminated

Initiation date

2016-08-24

Report date

2016-11-16

Termination date

2017-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2017