FDA-Drug2016-11-16Class II

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

Sandoz Inc
Hazard

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

Sold states
TN
Affected count
42,740 cartons (24 count carton from 7 total lots)
Manufactured in
100 College Rd W, Princeton, NJ, United States
Products
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

Official notice

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

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