# FDA recall D-741-2014

> **Novartis Consumer Health** · Class III · drug recall initiated 2013-05-15.

## Product

Maximum Strength Comtrex ,Severe Cold & Sinus  Acetaminophen 325mg, Chlorpheniramine Maleate 2mg,  Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24

## Reason for recall

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

## Distribution

Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.

## Key facts

- **Recall number:** D-741-2014
- **Recalling firm:** Novartis Consumer Health
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-15
- **Report date:** 2014-01-22
- **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-741-2014

## Citation

> AI Analytics. FDA recall D-741-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-741-2014. Source: US FDA. Licensed CC0.

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