Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bott...

FDA Recall #D-0563-2023 — Class II — March 31, 2023

Recall #D-0563-2023 Date: March 31, 2023 Classification: Class II Status: Ongoing

Product Description

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

Reason for Recall

CGMP deviation: product outside labeled storage temperature requirements.

Recalling Firm

Family Dollar Stores, Llc. — Chesapeake, VA

Classification

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

Product Type

Drugs

Product Quantity

Pending.

Distribution

Nationwide within the United States

Code Information

SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated