# FDA recall D-1242-2014

> **GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline** · Class III · drug recall initiated 2014-02-20.

## Product

Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.

## Reason for recall

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

## Distribution

U.S. Nationwide

## Key facts

- **Recall number:** D-1242-2014
- **Recalling firm:** GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-02-20
- **Report date:** 2014-04-30
- **Termination date:** 2017-01-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aiken, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1242-2014

## Citation

> AI Analytics. FDA recall D-1242-2014. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1242-2014. Source: US FDA. Licensed CC0.

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