Drug Enforcement D-0627-2024

Label mix-up: Carton incorrectly labeled.

Status

Completed

Classification

Class III

Report Date

August 14, 2024

Termination Date

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Product Information

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
Product quantity
21,192 Bottles
Reason for recall
Label mix-up: Carton incorrectly labeled.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.

Location & Firm

Recalling firm
Granules Consumer Health Inc.
Address
7413 Cushing Rd Ste 145

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0627-2024
Event ID
94981
Recall initiation date
July 18, 2024
Center classification date
August 6, 2024
Code info
Lot #: 31670346AA, Exp 12/31/2026
More code info
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