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Class II · ModerateRecall completed

Transderm Scop (scopolamine) Transdermal System

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540
Distributed by / forSandoz Inc
NDC66758-208-58
Show the full FDA record
Full product labelTransderm 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.
Recalling firmSandoz Inc
DistributionNationwide in the USA and Puerto Rico
Quantity157,922 cartons
Recall initiated2017-02-02
Report date2017-03-01
Recall completed2017-10-24
Recall numberD-0481-2017
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.