# FDA recall D-022-2014

> **Novartis Consumer Health** · Class III · drug recall initiated 2013-09-03.

## Product

Loratadine, USP 10 mg, Antihistamine, packaged in blister packs.  All manufactured by Novartis Consumer Health, Inc, Lincoln, NE / There are 7 different labels under which this product is packaged but the active ingredient is the same.    1) DOLLAR GENERAL LABEL:  DG Health Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 60 tablet blister packs (UPC code: 300436122) and 30 tablet blister packs (UPC code: 300676122304). Distributed by Dolgencorp, LLC, Goodlettsville, TN.    2) FAMILY DOLLAR LABEL:  Family Wellness Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 032251004292). Distributed by Family Dollar Services, Inc, Matthews, NC.    3) FAMILY DOLLAR LABEL Family Dollar Allergy Relief, Loratadine, USP 10 mg, Antihistamine, packaged in 30 tablet blister packs (UPC code: 400910131502). Manufactured by Novartis Consumer Health, Inc, Lincoln, NE and Distributed by Family Dollar Services, Inc, Charlotte, NC.    4) TARGE

## Reason for recall

Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-022-2014
- **Recalling firm:** Novartis Consumer Health
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-03
- **Report date:** 2013-12-04
- **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-022-2014

## Citation

> AI Analytics. FDA recall D-022-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-022-2014. Source: US FDA. Licensed CC0.

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