# FDA recall D-748-2014

> **Novartis Consumer Health** · Class II · drug recall initiated 2013-06-18.

## Product

Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton,  Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3.    Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.

## Reason for recall

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

## Distribution

Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.

## Key facts

- **Recall number:** D-748-2014
- **Recalling firm:** Novartis Consumer Health
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-18
- **Report date:** 2014-01-29
- **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-748-2014

## Citation

> AI Analytics. FDA recall D-748-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-748-2014. Source: US FDA. Licensed CC0.

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