# FDA recall D-0383-2015

> **Taro Pharmaceuticals U.S.A., Inc.** · Class II · drug recall initiated 2014-12-30.

## Product

Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.

## Reason for recall

Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0383-2015
- **Recalling firm:** Taro Pharmaceuticals U.S.A., Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-30
- **Report date:** 2015-02-11
- **Termination date:** 2018-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hawthorne, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0383-2015

## Citation

> AI Analytics. FDA recall D-0383-2015. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0383-2015. Source: US FDA. Licensed CC0.

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