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Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, pac...

FDA Recall #D-0627-2024 — Class III — July 18, 2024

Recall #D-0627-2024 Date: July 18, 2024 Classification: Class III Status: Terminated

Product Description

Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

Reason for Recall

Label mix-up: Carton incorrectly labeled.

Recalling Firm

Granules Consumer Health Inc. — Manassas, VA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

21,192 Bottles

Distribution

Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.

Code Information

Lot #: 31670346AA, Exp 12/31/2026

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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