Transderm Scop — Class II drug recall D-0481-2017
Terminated recall by Sandoz Inc, reported 2017-03-01, distributed nationwide. Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut t
| Recall number | D-0481-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2017-02-02 |
| Classified | 2017-02-17 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2017-10-24 |
| Distributed | Nationwide (US) |
| Quantity | 157,922 cartons |
| Reason classes | labeling |
| NDC | 66758-0208-54, 66758-0208-58 |
| Lot numbers | 06/19, 07/19, 6323Q11, 6328Q11, 6355Q11 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0481-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.