# FDA recall D-0481-2017

> **Sandoz Inc** · Class II · drug recall initiated 2017-02-02.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0481-2017
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-02
- **Report date:** 2017-03-01
- **Termination date:** 2017-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0481-2017

## Citation

> AI Analytics. FDA recall D-0481-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0481-2017. Source: US FDA. Licensed CC0.

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