Drug 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.
D-0383-2015
Product summary
- Event
- Event 70183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,684 Bottles
- Official record key
drug-enforcement:D-0383-2015
Official wording
Reason: Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Code information: Lot #: A4105, Exp 12/2016
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance