D-0300-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2019
- Initiation Date
- September 27, 2019
- Termination Date
- August 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182,986 bottles
Product Description
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8
Reason for Recall
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: E875131667, E875231667, Exp 4/20; J871033189, J871133189, Exp 9/20; A972934375, A973034375, Exp 12/20