# FDA recall D-577-2013

> **Novartis Consumer Health** · Class III · drug recall initiated 2013-02-19.

## Product

Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX only, a) Packaged in 20 gm tubes, NDC 63481-684-83 (physician sample product) and b) 100 gm tubes, NDC 63481-684-47 (the 100 g tubes are also packaged 3/100-g tubes/packs (UPC code: 363481684030 NDC code: 6348168403) and 5/100-g tubes/packs (UPC code: 363481684054 NDC code: 6348168405),  Marketed by Endo Pharmaceuticals Inc., Chadds Ford, PA and Manufactured by Novartis Consumer Health, Inc, Parsippany, NJ.

## Reason for recall

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

## Distribution

Nationwide and Puerto Rico, and Panama.  Military distribution made.

## Key facts

- **Recall number:** D-577-2013
- **Recalling firm:** Novartis Consumer Health
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-02-19
- **Report date:** 2013-06-12
- **Termination date:** 2014-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincoln, NE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-577-2013

## Citation

> AI Analytics. FDA recall D-577-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-577-2013. Source: US FDA. Licensed CC0.

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