FDA recall D-0383-2015

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

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

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