FDAClass IINovember 6, 2019

Children's Ibuprofen Oral Suspension USP recall

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04

Why was Children's Ibuprofen Oral Suspension USP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: A972834374, Exp 12/20

Product
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
Quantity
5,280 bottles
Distribution
U.S.A. Nationwide
Recall date
November 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls