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Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye ...

FDA Recall #D-0337-2019 — Class II — November 26, 2018

Recall #D-0337-2019 Date: November 26, 2018 Classification: Class II Status: Terminated

Product Description

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.

Reason for Recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

Recalling Firm

Tris Pharma Inc. — Monmouth Junction, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

20,736 bottles

Distribution

One distributor in PA who further distributed Nationwide in the USA.

Code Information

Lot #: 00717024A, Exp 08/19

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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