August 2016 FDA Recall Drug by Sandoz Inc
D-0133-2017 - Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

This Class II drug recall was voluntarily initiated by Sandoz Inc on August 24, 2016 for the product Drug. The FDA reported the reason for recall as defective delivery system; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-0133-2017

Reason for Recall
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Initiated
08-24-2016
Reported
11-16-2016
Quantity
42,740 cartons (24 count carton from 7 total lots)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75168
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-07-2017
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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.