PlainRecalls
FDA Drug Moderate Class II Terminated

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

Reported: November 6, 2019 Initiated: September 27, 2019 #D-0301-2020

Product Description

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

Reason for Recall

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Details

Units Affected
5,190 bottles
Distribution
U.S.A. Nationwide
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 5,190 bottles.
Why was this product recalled?
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 6, 2019. Severity: Moderate. Recall number: D-0301-2020.