The Recall Desk
SevereFDA (Drugs)·D-0133-2017·Announced 2016-11-16

Sandoz Recalls Transderm Scop Patches Due to Defective Delivery System

Sandoz Inc is recalling 42,740 cartons of Transderm Scop (scopolamine) transdermal systems in Tennessee due to a defective delivery system that may alter drug release.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a defect that may alter drug release and potentially cause serious adverse health consequences.

Plain-English summary

Sandoz Inc is recalling 42,740 cartons of Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack. The affected products are distributed in Tennessee and include seven specific lots with expiration dates ranging from June 2018 to February 2019. The recall is classified as FDA Class II.

The recall is being conducted because of a defective delivery system. Reports indicate that the product may be damaged in a way that alters the predicted release of scopolamine following transdermal application. This defect could affect the intended therapeutic effect of the medication.

Consumers and healthcare providers should check their inventory for the specific NDC codes and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations. Patients currently using the medication should consult their healthcare provider for guidance on alternative treatments.

The recalled product

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
Manufacturer
Sandoz Inc
Category
Drug — Transdermal Patch
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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.

Distribution

Distributed in 1 state:

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