# FDA recall D-846-2013

> **Novartis Consumer Health** · Class II · drug recall initiated 2013-06-06.

## Product

Parsel Plus (reference US product: Excedrin Tension Headache)  (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela.      The foreign packaging do not have NDC number    This product was only distributed to Novartis Brazil by the recalling firm

## Reason for recall

Defective container: products are packaged in pouches which may not have been fully sealed

## Distribution

Nationwide, Puerto Rico, Brazil and Panama

## Key facts

- **Recall number:** D-846-2013
- **Recalling firm:** Novartis Consumer Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-06
- **Report date:** 2013-08-14
- **Termination date:** 2014-11-04

- **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-846-2013

## Citation

> AI Analytics. FDA recall D-846-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-846-2013. Source: US FDA. Licensed CC0.

---

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