The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0481-2017·Announced 2017-03-01

Sandoz Recalls Transderm Scop Patches Due to Incorrect Labeling Instructions

Sandoz Inc. is recalling Transderm Scop patches because the outer carton contains incorrect instructions for cutting the patch.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a minor labeling error on the outer carton where the inner pouch is correctly labeled, fitting the rubric for moderate severity.

Plain-English summary

Sandoz Inc. is recalling Transderm Scop (scopolamine) Transdermal Systems, 1.5 mg, manufactured by ALZA Corporation. The recall involves 157,922 cartons distributed nationwide in the USA and Puerto Rico. The affected lots are 6323Q11 and 6328Q11 (Exp 06/19) and 6355Q11 (Exp 07/19).

The recall is due to a labeling error on the outer carton. The carton incorrectly states "Do cut the patch" for Step 2, whereas the correct instruction is "Do not cut the patch." The pouch containing the individual patch is labeled correctly with the proper instructions.

Consumers should check their Transderm Scop cartons for the affected lot numbers and expiration dates. If the carton contains the incorrect instruction "Do cut the patch," they should contact their healthcare provider or Sandoz Inc. for further instructions.

The recalled product

Product
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
Manufacturer
Sandoz Inc
Category
Drug — Transdermal Patch
Hazard
Affected units
157,922

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)

  • Lot #: 6323Q11
  • 6328Q11
  • Exp 06/19
  • 6355Q11
  • Exp 07/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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