# FDA recall D-0133-2017

> **Sandoz Inc** · Class II · drug recall initiated 2016-08-24.

## Product

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054

## Reason for recall

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

## Distribution

TN

## Key facts

- **Recall number:** D-0133-2017
- **Recalling firm:** Sandoz Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-24
- **Report date:** 2016-11-16
- **Termination date:** 2017-06-07

- **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-0133-2017

## Citation

> AI Analytics. FDA recall D-0133-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0133-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*