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D-0627-2024Class III

Granules Consumer Health Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Granules Consumer Health Inc.
Product type
Drug
Status
Terminated
Report date
2024-08-14
Distribution
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Firm state
VA
Product quantity
21,192 Bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Label mix-up: Carton incorrectly labeled.

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

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →