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FDAFDA · Food and drugs·Recall number D-0133-2017

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

Published November 16, 2016 · Recall initiated: August 24, 2016

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Sandoz Inc
Distributor
TN
Lot
NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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