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: 5167

FDA recall notice · announced February 11, 2015 · Taro Pharmaceuticals U.s.a

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot #: A4105, Exp 12/2016
Quantity: 36,684 Bottles
Status: Terminated
Products in this recall event:
- 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 Phar (D-0383-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.