CLASS II Drug recall · Reported 1 Mar 2017 · FDA Enforcement Report
Transderm Scop (scopolamine) Transdermal System, 1.5 mg recalled
Sandoz is recalling Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (, distributed nationwide in the US. The recall was initiated on 2 Feb 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0481-2017
- FDA event ID
- 76435
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Feb 2017
- FDA classified
- 17 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Feb 2017 | Recall initiated by company | |
| 17 Feb 2017 | Classified by FDA | +15 days |
| 1 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 6323Q11, 6328Q11, Exp 06/19; 6355Q11, Exp 07/19
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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